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Neuromodulation

Sound Therapy for Sleep Disorders (SLEEPFAST Trial)

N/A
Waitlist Available
Research Sponsored by Elemind Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subthreshold to Moderately severe Clinical insomnia (PSQI > 6)
Individuals that are not actively being treated for anxiety, insomnia, ADHD or other psychological disorders with medications
Must not have
Self-report of being diagnosed with apnea
Current or past history of a neurological disorder or psychiatric illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the completion of the study (7-14 days).
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a headband that helps adults with sleep problems by playing sounds to improve their sleep.

Who is the study for?
This trial is for individuals who take 30 minutes or more to fall asleep and often wake up at night. They should have moderate insomnia symptoms, not be treated for certain psychological disorders with medications, and must understand English. Excluded are those with a BMI over 33, sleep apnea, neurological or psychiatric illness history, severe insomnia or anxiety disorder risk, substance abuse issues, metal implants in the brain or cardiac pacemakers.
What is being tested?
The study tests if Elemind Neuromodulation (ENMod), which is auditory stimulation timed with brain waves during sleep onset as measured by EEG can help people fall asleep faster.
What are the potential side effects?
Potential side effects aren't specified but may include discomfort from wearing the EEG device during sleep and possible disturbances from the auditory stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have trouble sleeping, scoring over 6 on the PSQI.
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I am not currently on medication for anxiety, insomnia, ADHD, or other mental health issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with apnea.
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I have or had a brain or mental health condition.
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I have severe insomnia.
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I have had seizures or there is a history of seizures in my family.
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I have had a brain injury or unexplained fainting.
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I am currently taking medication for depression, ADHD, blood pressure, or using cannabis products.
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I have been diagnosed with hearing loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the completion of the study (7-14 days).
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the completion of the study (7-14 days). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
Secondary study objectives
Change in Sleep Efficiency During Sham Block Compared to Stimulation Block
Change in Subjective Daytime Sleepiness (Karolinska Sleepiness Scale) from Sham Block Compared to Stimulation Block
Change in Subjective Sleep Onset Latency (SOL) from Sham Block Compared to Stimulation Block
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Wake After Sleep OnsetExperimental Treatment1 Intervention
This arm tests active stimulation during sleep onset, as well as additional stimulation if participants wake up during the night. One of 4 possible conditions are randomized for each stimulation even (within subject and within nights): Stimulation locked to alpha peak phase, stimulation locked to alpha trough phase, white noise (active sham), and no sound (control).
Group II: Sleep Onset Latency CrossoverExperimental Treatment1 Intervention
Arm 1 is a crossover arm in which participants receive one block of active stimulation (experimental) and a second block in which the device is worn and actively recording, but not delivering phase-locked auditory stimulation (sham). The order of blocks is randomized for each participant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elemind Neuromodulation (ENMod)
2020
N/A
~200

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for sleep disorders often aim to regulate the sleep-wake cycle and improve sleep quality. Auditory stimulation synchronized with alpha oscillations works by delivering sounds at specific phases of brain activity, potentially accelerating sleep onset by enhancing the natural transition into sleep. This method leverages the brain's natural rhythms to promote faster and more efficient sleep initiation. For sleep patients, understanding these mechanisms is crucial as it highlights the importance of treatments that align with the body's natural processes, potentially offering more effective and less invasive options for improving sleep quality.
An evaluation of tailored psychological treatment of insomnia.

Find a Location

Who is running the clinical trial?

Elemind Technologies, Inc.Lead Sponsor

Media Library

Elemind Neuromodulation (ENMod) (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05743114 — N/A
Sleep Clinical Trial 2023: Elemind Neuromodulation (ENMod) Highlights & Side Effects. Trial Name: NCT05743114 — N/A
Sleep Research Study Groups: Sleep Onset Latency Crossover, Wake After Sleep Onset
Elemind Neuromodulation (ENMod) (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05743114 — N/A
~34 spots leftby Dec 2025