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

NCT ID: NCT03050372

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-12-31

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.

Conditions

Insomnia, Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Low Field Magnetic Stimulation

LFMS - Active

Group Type: EXPERIMENTAL

LFMS - Active

Intervention Type: DEVICE

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

Group Type: SHAM_COMPARATOR

LFMS - Sham

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tal Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Uhde, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00055979

Identifier Type: -

Identifier Source: org_study_id