Clinical trial NCT03050372: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insomnia, Primary
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Tal Medical, Inc.
First posted: 2017-02-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
timeFrame: 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
measure: Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
timeFrame: 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
measure: Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
timeFrame: 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
measure: Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
timeFrame: 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
measure: Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
timeFrame: 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
measure: MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
timeFrame: 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
Secondary outcomes:
measure: Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
timeFrame: 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
measure: Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
timeFrame: 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
measure: Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
timeFrame: 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
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Thomas Uhde, MD
role: PRINCIPAL_INVESTIGATOR
References: