Insomnia, PrimaryNCT03050372

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

A study testing LFMS - Active in people with Insomnia, Primary, run by Medical University of South Carolina at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Insomnia, Primary
What is being tested?: LFMS - Active
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Nov 2016to Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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

Who cannot join

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

Show all 24Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: 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.

Conditions: Insomnia, Primary
Being tested: LFMS - Active, LFMS - Sham
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LFMS - ActiveDevice
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)
LFMS - ShamDevice
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)

Study groups in NCT03050372
Study group	Role	What they receive
Active Low Field Magnetic Stimulation	Experimental	LFMS - Active Receives: Device: LFMS - Active
Sham Low Field Magnetic Stimulation	Sham comparator	LFMS - Sham Receives: Device: LFMS - Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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)
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 (3)

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.
Measured: 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
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.
Measured: 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
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Dec 2018

First posted10 Feb 2017
Study startNov 2016
Primary completionDec 2018
Study completionDec 2018

Why it stopped: Funding no longer available

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Insomnia, PrimaryStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03050372
Sponsor's protocol ID: Pro00055979
Status last verified: Feb 2020
First submitted: 16 Dec 2016
Last updated: 13 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Insomnia, Primary trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-Blind, Sham-Controlled Crossover Pilot Study of Low Field Magnetic Stimulation (LFMS) on Subjective and Objective Measures of Sleep
ClinicalTrials.gov ID: NCT03050372
Acronym / sponsor ID: Pro00055979
Conditions: Insomnia, Primary
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding no longer available
Enrolment: 12 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: Tal Medical, Inc.
Study start: Nov 2016
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 10 Feb 2017 (actual)
Results: Posted 13 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Active Low Field Magnetic Stimulation	Experimental	Device: LFMS - ActiveLFMS - Active
Sham Low Field Magnetic Stimulation	Sham comparator	Device: LFMS - ShamLFMS - Sham

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LFMS - ActiveA 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)	Device	Active Low Field Magnetic Stimulation
LFMS - ShamA 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)	Device	Sham Low Field Magnetic Stimulation

Primary outcome

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

3 secondary outcomes

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

Results and safety

Results posted to the registry on 13 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Low Field Magnetic Stimulation (LFMS), Then Sham LFMS	6	5
Sham Low Field Magnetic Stimulation (LFMS), Then Active LFMS	6	6

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

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. Mean (Standard Deviation). Unit: minutes

Measure	Active Low Field Magnetic Stimulation n = 10	Sham Low Field Magnetic Stimulation n = 10
Baseline SOL	43.35 (25.95)	43.35 (25.95)
Intervention LFMS; two-night average in each arm	53.88 (40.03)	46.35 (34.50)
Change from Baseline SOL	10.53 (31.67)	3.00 (22.77)

Active Low Field Magnetic Stimulation vs Sham Low Field Magnetic Stimulation: p = 0.329, t-test, 2 sided
Active Low Field Magnetic Stimulation: p = 0.321, t-test, 2 sided
Sham Low Field Magnetic Stimulation: p = 0.687, t-test, 2 sided

Population analysed: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.

Primary outcome: Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)

Measure	Active Low Field Magnetic Stimulation n = 10	Sham Low Field Magnetic Stimulation n = 10
Baseline WASO	80.85 (78.41)	80.85 (78.41)
Sham or Active LFMS (two-night average)	54.80 (46.87)	56.00 (31.31)
Change from Baseline WASO	26.05 (41.69)	24.85 (59.75)

Active Low Field Magnetic Stimulation vs Sham Low Field Magnetic Stimulation: p = 0.925, t-test, 2 sided
Active Low Field Magnetic Stimulation: p = 0.08, t-test, 2 sided
Sham Low Field Magnetic Stimulation: p = 0.221, t-test, 2 sided

Primary outcome: Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)

Measure	Active Low Field Magnetic Stimulation n = 10	Sham Low Field Magnetic Stimulation n = 10
Baseline TST	359.60 (86.60)	359.60 (86.60)
Sham or Active LFMS (two-night average)	370.40 (80.96)	388.53 (73.02)
Change from Baseline TST	10.80 (60.50)	28.93 (82.73)

Active Low Field Magnetic Stimulation vs Sham Low Field Magnetic Stimulation: p = 0.197, t-test, 2 sided
Active Low Field Magnetic Stimulation: p = 0.586, t-test, 2 sided
Sham Low Field Magnetic Stimulation: p = 0.298, t-test, 2 sided

Primary outcome: Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)

Measure	Active Low Field Magnetic Stimulation n = 10	Sham Low Field Magnetic Stimulation n = 10
Baseline SE	0.72 (0.16)	0.72 (0.16)
Sham or Active LFMS (two-night average)	0.77 (0.11)	0.79 (0.08)
Change from Baseline SE	0.05 (0.11)	0.07 (0.15)

Active Low Field Magnetic Stimulation vs Sham Low Field Magnetic Stimulation: p = 0.424, t-test, 2 sided
Active Low Field Magnetic Stimulation: p = 0.210, t-test, 2 sided
Sham Low Field Magnetic Stimulation: p = 0.190, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Beginning with the baseline adaptation night adverse effect were actively monitored over the duration of the study interventions (distributed over approx. two weeks for each subject); monitoring specifically included all 5 nights spent in the sleep lab (adaptation night #1, first intervention nights 2&3, washout period, and second intervention nights 4&5). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Entire Study Population	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Uhde, MD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LFMS - Active in people with Insomnia, Primary, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) (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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03050372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.