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



Status:Suspended
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:7/20/2018
Start Date:November 2016
End Date:August 2019

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Trial Summary
Trial Overview
Inclusion Criteria

Double-Blind, Sham-Controlled Crossover Pilot Study of Low Field Magnetic Stimulation (LFMS) on Subjective and Objective Measures of Sleep

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.


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.
We found this trial at
1
site
Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-4636
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