What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for sleep disorders include cognitive behavioral therapy for insomnia (CBT-I), pharmacotherapy (such as benzodiazepines and non-benzodiazepine sleep aids), and neuromodulation techniques like neurofeedback. Side effects of pharmacotherapy can include daytime drowsiness, dizziness, and dependency. Neurofeedback, which targets abnormal brain activity, has shown improvements in subjective sleep but may involve a placebo effect and requires more robust studies to confirm efficacy. Mild side effects reported in neuromodulation studies include sensations like tingling or lightheadedness. Specific side effects for auditory stimulation synchronized with alpha oscillations are not well-documented, but general neuromodulation side effects can be mild and transient.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of sleep disorders, including benzodiazepines like triazolam and non-benzodiazepine hypnotics such as zolpidem and eszopiclone. Additionally, melatonin receptor agonists like ramelteon and orexin receptor antagonists like suvorexant have been approved. While these treatments primarily focus on pharmacological interventions, emerging research, such as the study on auditory stimulation synchronized with alpha oscillations, represents a novel, non-pharmacological approach to potentially accelerate sleep onset.

What other types of research exist?

Promising novel alternatives for sleep patients in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which has shown effectiveness in various neurological conditions and may be adapted for sleep therapy. 2) Wearable technologies that monitor physiological parameters and provide feedback to improve sleep quality. 3) AI-driven personalized therapy systems that adapt treatments based on individual sleep patterns and responses.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the completion of the study (7-14 days).

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

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

0 / 9Eligibility criteria met

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.