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Study of Low Field Magnetic Stimulation (LFMS) on Measures of Sleep

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ClinicalTrials.gov Identifier: NCT03050372
Recruitment Status : Terminated (Funding no longer available)
First Posted : February 10, 2017
Results First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Tal Medical, Inc.
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Insomnia, Primary
Interventions Device: LFMS - Active
Device: LFMS - Sham
Enrollment 12
Recruitment Details Eligibility screening was completed over the phone by trained sleep personnel; sleep laboratory is located at the Medical University of South Carolina's Institute of Psychiatry at 67 President St., Charleston S.C. This is a crossover study; each participant is exposed to both active and sham conditions.
Pre-assignment Details N=209 subjects screened from 07/2016-07/2017; N=193 participants were excluded prior to PSG because they declined to participate (N=49), did not meet the age criterion (N=28), did not meet the sleep criterion (N=61), had co-morbid psychiatric disorders (N=42), or for other reasons (N=13); N=4 excluded after consent due to medication/baby/no-show.
Arm/Group Title Active Low Field Magnetic Stimulation (LFMS), Then Sham LFMS Sham Low Field Magnetic Stimulation (LFMS), Then Active LFMS
Hide Arm/Group Description

Adaptation Night; then two consecutive nights of Active LFMS; after washout two consecutive nights of Sham LFMS

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab

Adaptation Night; then two consecutive nights of Sham LFMS; after washout followed by two consecutive nights of Active LFMS

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes); then participants complete a full night of sleep in the sleep lab

Period Title: Adaptation Night (Night #1 PSG)
Started 6 6
Completed 5 [1] 6
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
[1]
N=1 subject removed from study due to mild sleep apnea during adaptation night
Period Title: First Intervention (Nights #2 and #3)
Started 5 6
Completed 5 6
Not Completed 0 0
Period Title: Second Intervention (Nights #4 and #5)
Started 5 6
Completed 5 5 [1]
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
[1]
N=1 subject (blind only broken after double-blind analysis) moved out off State; lost to study
Arm/Group Title All Study Participants
Hide Arm/Group Description

Participants are randomized to receive either two consecutive nights of "Active Low Field Magnetic Stimulation" followed by "Sham Low Field Magnetic Stimulation" or vice versa.

Active Low Field Magnetic Stimulation LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

Sham Low Field Magnetic Stimulation LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
35.58  (8.512)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
1
   8.3%
Not Hispanic or Latino
11
  91.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  16.7%
White
10
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
Height  
Mean (Standard Deviation)
Unit of measure:  Inch
Number Analyzed 12 participants
67.83  (3.54)
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbm (pound mass)
Number Analyzed 12 participants
184.83  (35.70)
PSQI (Pittsburgh Sleep Quality Inventory)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants
11.58  (2.68)
[1]
Measure Description: Pittsburgh Sleep Quality Inventory (PSQI) is a well established 10-question questionnaire (24 items incl. sub-questions 5a-j and 10a-e) that assesses subjective sleep quality, -latency, -duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, daytime dysfunction. Individual items' responses are in the range of 0-3; a total PSQI score is derived by first deriving 7 equally weighted components from all 24 responses; each component is in the range of 0-3, resulting in a total score (sum of all components) of 0-21; a total PSQI score of >=5 is associated with poor sleep.
1.Primary Outcome
Title Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Hide Description SOL is the time of transition from wake to sleep (non-REM S1) measured in minutes; a validated objective measure extracted directly from full-night polysomnography (PSG). SOL of 0-5min is associated with severe sleep deprivation; 5-10min is moderate sleep debt; 10-15min indicates mild sleep debt; 15-20min is little-to-no sleep debt; and >20min is considered to be associated with no sleep debt.
Time Frame Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Hide Outcome Measure Data
Hide Analysis Population Description
12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.
Arm/Group Title Active Low Field Magnetic Stimulation Sham Low Field Magnetic Stimulation
Hide Arm/Group Description:

LFMS - Active

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

LFMS - Sham

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline SOL 43.35  (25.95) 43.35  (25.95)
Intervention LFMS; two-night average in each arm 53.88  (40.03) 46.35  (34.50)
Change from Baseline SOL 10.53  (31.67) 3.00  (22.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation, Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of SOL for active/sham LFMS are equal; Ha: Means differ

Note this paired t-test is equivalent to:

H0: Mean changes from Baseline SOL for active/sham LFMS are equal Ha: Means differ

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%.
Statistical Test of Hypothesis P-Value 0.329
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of SOL for Baseline and Active LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline SOL for Active LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.321
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of SOL for Baseline and Sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline SOL for Sham LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.687
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Hide Description Total time awake after initial sleep onset in minutes; validated objective measure directly extracted from polysomnography (PSG); we average measures from both consecutive nights under each of the two interventions (Sham or Active LFMS)
Time Frame Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Hide Outcome Measure Data
Hide Analysis Population Description
12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.
Arm/Group Title Active Low Field Magnetic Stimulation Sham Low Field Magnetic Stimulation
Hide Arm/Group Description:

LFMS - Active

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

LFMS - Sham

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline WASO 80.85  (78.41) 80.85  (78.41)
Sham or Active LFMS (two-night average) 54.80  (46.87) 56.00  (31.31)
Change from Baseline WASO 26.05  (41.69) 24.85  (59.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation, Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of WASO for active/sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to:

H0: Mean changes from Baseline WASO for active/sham LFMS are equal Ha: Means differ

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.925
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of WASO for Baseline and Active LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline WASO for Active LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of WASO for Baseline and Sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline WASO for Sham LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.221
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Hide Description Total Sleep Time is the total time spent sleeping (non-wake stages S1-S5) in minutes; validated objective measure directly extracted from polysomnography (PSG).
Time Frame Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Hide Outcome Measure Data
Hide Analysis Population Description
12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.
Arm/Group Title Active Low Field Magnetic Stimulation Sham Low Field Magnetic Stimulation
Hide Arm/Group Description:

LFMS - Active

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

LFMS - Sham

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline TST 359.60  (86.60) 359.60  (86.60)
Sham or Active LFMS (two-night average) 370.40  (80.96) 388.53  (73.02)
Change from Baseline TST 10.80  (60.50) 28.93  (82.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation, Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of TST for active/sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to:

H0: Mean changes from Baseline TST for active/sham LFMS are equal Ha: Means differ

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.197
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of TST for Baseline and Active LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline TST for Active LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.586
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of TST for Baseline and Sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline TST for Sham LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.298
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Hide Description Sleep Efficiency (SE) is an objective measure of sleep quality derived from polysomnography (PSG); it is a unitless measure defined as the total sleep time (TST) divided by total time in bed (TiB); it can theoretically range from 0 (no sleep at all) to 1 (slept the entire time in bed). Values close to zero indicate very little time spent sleeping while values close to one indicate a large sleep utilization while in bed.
Time Frame Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Hide Outcome Measure Data
Hide Analysis Population Description
12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.
Arm/Group Title Active Low Field Magnetic Stimulation Sham Low Field Magnetic Stimulation
Hide Arm/Group Description:

LFMS - Active

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

LFMS - Sham

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: unitless ratio (0 to 1)
Baseline SE 0.72  (0.16) 0.72  (0.16)
Sham or Active LFMS (two-night average) 0.77  (0.11) 0.79  (0.08)
Change from Baseline SE 0.05  (0.11) 0.07  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation, Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of SE for active/sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to:

H0: Mean changes from Baseline SE for active/sham LFMS are equal Ha: Means differ

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.424
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of SE for Baseline and Active LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline SE for Active LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.210
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of SE for Baseline and Sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline SE for Sham LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.190
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Hide Description Ease of Sleep (EOS) is assessed after each night as a subjective measure; participants self-rate their ease to fall asleep on a visual analog scale 0-100mm where 0mm is associated with not easy at all (no sleep) and 100mm is associated with no problems to fall asleep. EOS is a proxy measure for a participants sleepiness.
Time Frame Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Hide Outcome Measure Data
Hide Analysis Population Description
12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.
Arm/Group Title Active Low Field Magnetic Stimulation Sham Low Field Magnetic Stimulation
Hide Arm/Group Description:

LFMS - Active

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

LFMS - Sham

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-100mm)
Baseline EOS 63.30  (30.99) 63.30  (30.99)
Sham or Active LFMS (two-night average) 51.95  (26.47) 47.70  (17.76)
Change from Baseline EOS -11.35  (25.70) -15.60  (26.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation, Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of EOS for active/sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to:

H0: Mean changes from Baseline EOS for active/sham LFMS are equal Ha: Means differ

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.535
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of EOS for Baseline and Active LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline EOS for Active LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.196
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of EOS for Baseline and Sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline EOS for Sham LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Primary Outcome
Title MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Hide Description MUSC Sleep Quality Score (SQS) is assessed after each night as a subjective measure; participants self-rate their perceived sleep quality on a 0-6 scale where 0 is associated with extremely poor sleep quality and 6 is associated with extremely good sleep quality.
Time Frame Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Hide Outcome Measure Data
Hide Analysis Population Description
12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.
Arm/Group Title Active Low Field Magnetic Stimulation Sham Low Field Magnetic Stimulation
Hide Arm/Group Description:

LFMS - Active

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

LFMS - Sham

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: score on a scale (0-6)
Baseline SQS 1.90  (0.74) 1.90  (0.74)
Sham or Active LFMS (two-night average) 2.75  (0.82) 2.75  (1.25)
Change from Baseline SQS 0.85  (0.71) 0.85  (1.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation, Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of SQS for active/sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to:

H0: Mean changes from Baseline SQS for active/sham LFMS are equal Ha: Means differ

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of SQS for Baseline and Active LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline SQS for Active LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of SQS for Baseline and Sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline SQS for Sham LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Hide Description Number of Awakenings (#awake) is the integer number of nocturnal awakenings after initial sleep onset, i.e. a count.
Time Frame Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Hide Outcome Measure Data
Hide Analysis Population Description
12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.
Arm/Group Title Active Low Field Magnetic Stimulation Sham Low Field Magnetic Stimulation
Hide Arm/Group Description:

LFMS - Active

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

LFMS - Sham

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: awakenings
Baseline #awake Number Analyzed 10 participants 10 participants
19  (8.31) 19  (8.31)
Sham or Active LFMS (two-night average) Number Analyzed 10 participants 9 participants
17.45  (5.36) 21.17  (8.31)
Change from Baseline #awake Number Analyzed 10 participants 9 participants
-1.55  (5.30) 2.50  (6.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation, Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of #awake for active/sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to:

H0: Mean changes from Baseline #awake for active/sham LFMS are equal Ha: Means differ

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of #awake for Baseline and Active LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline #awake for Active LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.379
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of #awake for Baseline and Sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline #awake for Sham LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.284
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Hide Description Participants rate after each night how fatigued they feel on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot.
Time Frame Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Hide Outcome Measure Data
Hide Analysis Population Description
12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.
Arm/Group Title Active Low Field Magnetic Stimulation Sham Low Field Magnetic Stimulation
Hide Arm/Group Description:

LFMS - Active

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

LFMS - Sham

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-100mm)
Baseline fatigue 58.10  (24.73) 58.10  (24.73)
Sham or Active LFMS (two-night average) 52.65  (22.30) 45.45  (27.58)
Change from Baseline fatigue -5.45  (11.13) -12.65  (23.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation, Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of Fatigue for active/sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to:

H0: Mean changes from Baseline Fatigue for active/sham LFMS are equal Ha: Means differ

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.226
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of Fatigue for Baseline and Active LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline Fatigue for Active LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.156
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of Fatigue for Baseline and Sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline Fatigue for Sham LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Hide Description Participants rate after each night their ability to concentrate on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot. This is a subjective proxy measure for a restorative sleep / sleep quality.
Time Frame Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Hide Outcome Measure Data
Hide Analysis Population Description
12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.
Arm/Group Title Active Low Field Magnetic Stimulation Sham Low Field Magnetic Stimulation
Hide Arm/Group Description:

LFMS - Active

LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)

LFMS - Sham

LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-100mm)
Baseline concentration 46.80  (22.42) 46.80  (22.42)
Sham or Active LFMS (two-night average) 42.40  (19.58) 36.80  (20.37)
Change from Baseline concentration -4.40  (11.28) -10.00  (18.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation, Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of Concentration for active/sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to:

H0: Mean changes from Baseline Concentration for active/sham LFMS are equal Ha: Means differ

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.130
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Active Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of Concentration for Baseline and Active LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline Concentration for Active LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.249
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham Low Field Magnetic Stimulation
Comments

This is a crossover study; we use a paired t-test to test the hypothesis:

H0: Means of Concentration for Baseline and Sham LFMS are equal Ha: Means differ

Note this paired t-test is equivalent to a one-sample t-test:

H0: Mean changes from Baseline Concentration for Sham LFMS is equal 0 Ha: Mean is not equal zero

Type of Statistical Test Equivalence
Comments Significance level alpha=0.05; CI=95%
Statistical Test of Hypothesis P-Value 0.114
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Beginning with the baseline adaptation night adverse effect were actively monitored over the duration of the study interventions (distributed over approx. two weeks for each subject); monitoring specifically included all 5 nights spent in the sleep lab (adaptation night #1, first intervention nights 2&3, washout period, and second intervention nights 4&5)
Adverse Event Reporting Description Each study participant was further informed that adverse effects, should they occur outside the active monitoring period and/or after the study concluded, can be reported directly to either the sleep-lab manager, to the attending physician (T. Uhde), or to the clinical psychologist (A. Wilkerson).
 
Arm/Group Title Entire Study Population
Hide Arm/Group Description

All participants completed an adaptation night (night #1) in the sleep lab including baseline assessment. Participants were treatment randomized to receive, after the adaptation night in the sleep lab, either two consecutive nights (night #2,#3) of "Active Low Field Magnetic Stimulation" followed by two consecutive nights (night #4,#5) of "Sham Low Field Magnetic Stimulation", or vice versa. A washout period was permitted between nights #3 and #4 when the intervention changed.

Interventions:

Active Low Field Magnetic Stimulation A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (20 minutes before sleep)

Sham Low Field Magnetic Stimulation A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (20 minutes before sleep)

All-Cause Mortality
Entire Study Population
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Serious Adverse Events
Entire Study Population
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Entire Study Population
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas W. Uhde, M.D.
Organization: Medical University of South Carolina
Phone: 843-792-0028
EMail: uhde@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03050372    
Other Study ID Numbers: Pro00055979
First Submitted: December 16, 2016
First Posted: February 10, 2017
Results First Submitted: December 31, 2019
Results First Posted: February 13, 2020
Last Update Posted: February 13, 2020