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

Primary Purpose

Insomnia, Primary

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LFMS - Active
LFMS - Sham
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia, Primary

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Low Field Magnetic Stimulation

Sham Low Field Magnetic Stimulation

Arm Description

LFMS - Active

LFMS - Sham

Outcomes

Primary Outcome Measures

Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
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)
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)
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)
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)
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)
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.

Secondary Outcome Measures

Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
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)
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)
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.

Full Information

First Posted
December 16, 2016
Last Updated
February 12, 2020
Sponsor
Medical University of South Carolina
Collaborators
Tal Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03050372
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding no longer available
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Tal Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Low Field Magnetic Stimulation
Arm Type
Experimental
Arm Description
LFMS - Active
Arm Title
Sham Low Field Magnetic Stimulation
Arm Type
Sham Comparator
Arm Description
LFMS - Sham
Intervention Type
Device
Intervention Name(s)
LFMS - Active
Intervention Description
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
Intervention Name(s)
LFMS - Sham
Intervention Description
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)
Primary Outcome Measure Information:
Title
Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Description
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.
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
Title
Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Description
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)
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
Title
Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Description
Total Sleep Time is the total time spent sleeping (non-wake stages S1-S5) in minutes; validated objective measure directly extracted from polysomnography (PSG).
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
Title
Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Description
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.
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
Title
Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Description
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.
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
Title
MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Description
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.
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
Secondary Outcome Measure Information:
Title
Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Description
Number of Awakenings (#awake) is the integer number of nocturnal awakenings after initial sleep onset, i.e. a count.
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
Title
Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Description
Participants rate after each night how fatigued they feel on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot.
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
Title
Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Uhde, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

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

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