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

Medical University of South Carolina (MUSC)

Status

Terminated

Conditions

Insomnia, Primary

Treatments

Device: LFMS - Active

Device: LFMS - Sham

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03050372

Pro00055979

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.