Study of Low Field Magnetic Stimulation (LFMS) on Measures of Sleep
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| ClinicalTrials.gov Identifier: NCT03050372 |
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Recruitment Status :
Terminated
(Funding no longer available)
First Posted : February 10, 2017
Results First Posted : February 13, 2020
Last Update Posted : February 13, 2020
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| 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 |
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 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 |
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[1]
N=1 subject removed from study due to mild sleep apnea during adaptation night
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| 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 |
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[1]
N=1 subject (blind only broken after double-blind analysis) moved out off State; lost to study
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| Arm/Group Title | All Study Participants | |
|---|---|---|
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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) |
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| Overall Number of Baseline Participants | 12 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 12 participants | |
| 35.58 (8.512) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 12 participants | |
| Female |
6 50.0%
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| Male |
6 50.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 12 participants | |
| Hispanic or Latino |
1 8.3%
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| Not Hispanic or Latino |
11 91.7%
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| Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 12 participants | |
| American Indian or Alaska Native |
0 0.0%
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| Asian |
0 0.0%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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| Black or African American |
2 16.7%
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| White |
10 83.3%
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| More than one race |
0 0.0%
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| Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 12 participants |
| 12 | ||
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Height
Mean (Standard Deviation) Unit of measure: Inch |
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| Number Analyzed | 12 participants | |
| 67.83 (3.54) | ||
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Weight
Mean (Standard Deviation) Unit of measure: Lbm (pound mass) |
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| Number Analyzed | 12 participants | |
| 184.83 (35.70) | ||
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PSQI (Pittsburgh Sleep Quality Inventory)
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 12 participants | |
| 11.58 (2.68) | ||
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[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.
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| Name/Title: | Thomas W. Uhde, M.D. |
| Organization: | Medical University of South Carolina |
| Phone: | 843-792-0028 |
| EMail: | uhde@musc.edu |
| 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 |