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

• ClinicalTrials.gov Identifier: NCT03050372
• Recruitment Status: Terminated
• First Posted: February 10, 2017
• Results First Posted: February 13, 2020
• Last Update Posted: February 13, 2020
• Sponsor: Medical University of South Carolina
• Collaborator: Tal Medical, Inc.
• Information provided by (Responsible Party): Medical University of South Carolina

Tracking Information

• First Submitted Date: December 16, 2016
• First Posted Date: February 10, 2017
• Results First Submitted Date: December 31, 2019
• Results First Posted Date: February 13, 2020
• Last Update Posted Date: February 13, 2020
• Study Start Date: November 2016
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 12, 2020)

• Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) [ 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 ]
  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.
• Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) [ 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 ]
  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)
• Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) [ 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 ]
  Total Sleep Time is the total time spent sleeping (non-wake stages S1-S5) in minutes; validated objective measure directly extracted from polysomnography (PSG).
• Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) [ 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 ]
  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.
• Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) [ 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 ]
  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.
• MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) [ 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 ]
  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.

Original Primary Outcome Measures (submitted: February 9, 2017)

• Self-reported sleep (Pittsburgh Sleep Quality Inventory - Global Score) [ Time Frame: 2 weeks ]
  Well-validated questionnaire about perception of sleep quality
• Sleep Efficiency as measured by Polysomnography (PSG) [ Time Frame: 2 weeks ]
  Sleep parameter derived from overnight sleep study

Current Secondary Outcome Measures (submitted: February 12, 2020)

• Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) [ 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 ]
  Number of Awakenings (#awake) is the integer number of nocturnal awakenings after initial sleep onset, i.e. a count.
• Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) [ 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 ]
  Participants rate after each night how fatigued they feel on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot.
• Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) [ 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 ]
  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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Low Field Magnetic Stimulation (LFMS) on Measures of Sleep
• Official Title: Double-Blind, Sham-Controlled Crossover Pilot Study of Low Field Magnetic Stimulation (LFMS) on Subjective and Objective Measures of Sleep
• Brief Summary: Participants will be recruited and screened through ongoing studies in the sleep and anxiety disorders clinic. Participants with insomnia will be consented to complete several questionnaires, undergo a brief physical exam, provide a urinalysis, and undergo 5 nights of active or sham Low Field Magnetic Stimulation (LFMS) followed by an overnight sleep study. Each of the two treatment conditions (active versus sham) will be conducted on two consecutive nights. There will be no more than 7 days between the adaptation night and the first treatment condition and no more than 7 nights between each of the two-night treatment conditions . Thus, each participant who completes the full study will spend a total of 5 nights in the sleep laboratory and the time interval from the first adaptation night to completion of the study may range from 5-19 days for any particular individual.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Insomnia, Primary

Intervention

• Device: 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)
• Device: 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)

Study Arms

• Experimental: Active Low Field Magnetic Stimulation
  LFMS - Active
  Intervention: Device: LFMS - Active
• Sham Comparator: Sham Low Field Magnetic Stimulation
  LFMS - Sham
  Intervention: Device: LFMS - Sham

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 12, 2020): 12
• Original Estimated Enrollment (submitted: February 9, 2017): 20
• Actual Study Completion Date: December 2018
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Insomnia diagnosis per DSM-5 criteria
• Performing tasks in a timely manner (compared to the person's usual level of performance)
• Pittsburgh Sleep Quality Index (PSQI) > 6 and one of the following:
• Sleep Efficiency < 85% (per Consensus Sleep Diary)
• Insomnia Severity Index (ISI) score > 15
• Sleep latency (subjective) and/or time awake after sleep onset (subjective) >30 minutes.
• Not currently depressed (previous major depressive episodes and current antidepressant medication permitted as long as remission and current medication dosage has been stable for ≥ 1 month).
• Willing to refrain from alcohol for twenty-four hours before presenting to sleep lab for sleep studies
• BMI > 18 and < 50 kg/m2

Exclusion Criteria:

• Current major depressive episode
• Current substance-induced depressive disorder
• Self-reported use of benzodiazepines or hypnotic drugs in last two weeks
• Self-reported use of marijuana in previous 72 hours
• Alcohol Use Disorders Identification Test (AUDIT) score > 10
• Fagerstrom Test for Nicotine Dependence (FTND) score > 4
• Insomnia limited to early morning awakening (without difficulty initiating or maintaining sleep),
• Narcolepsy
• Seizure Disorder (not including childhood febrile seizures)
• Recent treatment with anticonvulsant medications
• Obstructive or central sleep apnea
• Circadian rhythm sleep-wake disorders
• Recurrent isolated sleep paralysis
• Current substance-induced insomnia
• Chronic pain disorder
• Daily Caffeine Consumption > 500 mg/d (Uhde, 1989)
• Restless legs syndrome
• Periodic Leg Movement Disorder
• Benzodiazepines or antipsychotic medications during past 30 days
• Presence of drugs of abuse (excluding marijuana, urinalysis)
• Pregnancy or plans to become pregnant
• History of severe allergic reactions to adhesive tape
• History of neurological disorder
• Conductive, ferromagnetic or other magnetic-sensitive metals in the head, neck, chest, upper arms, or any area that will be within 18 inches of the treatment coil.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03050372
• Other Study ID Numbers: Pro00055979
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: This process is still being discussed by investigators. Once plan is complete it will likely include protocol and primary outcome measures which may be accessed through peer reviewed publications.

• Responsible Party: Medical University of South Carolina
• Study Sponsor: Medical University of South Carolina
• Collaborators: Tal Medical, Inc.

Investigators

• Principal Investigator: Thomas Uhde, MD; Medical University of South Carolina

• PRS Account: Medical University of South Carolina
• Verification Date: February 2020