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Can a headband that plays pink noise cure insomnia in depressed people?

NCT ID NCT07553364

Symptom relief Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This pilot study tests whether a headband that delivers timed sound pulses (pink noise) can improve sleep in 25 people with both depression and insomnia. Participants wear the device nightly for four weeks, alternating between active stimulation and sham (placebo) sound. The goal is to see if the active stimulation helps them fall asleep faster and wake less during the night.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Elemind Neuromodulation Device (ENMod) delivering alpha phase-locked auditory stimulation (pink noise pulses)
What this could lead to
If it works, this could point toward a drug-free, at-home device to help people with depression fall asleep faster and wake less during the night.
What could go wrong
This is a very small, early feasibility study with only 25 people. The effect may be small or no better than sham (placebo) stimulation, and results may not apply to everyone with depression and insomnia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ability to complete overnight EEG study including placement of EEG leads * Ability to read and understand English * Presence of Insomnia * Moderate Depression * Home internet and smartphone (Android or Apple) device access Exclusion Criteria: * Presence of severe, untreated sleep apnea * Presence of restless leg syndrome * Significant neurological disease (e.g. Parkinson's disease, epilepsy) * Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation * Has active implanted device ( e.g. intracranial device, cochlear implant) * Currently deaf or experiencing hearing loss or using hearing aids * Currently taking medications that could alter EEG * Currently pregnant

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Conditions

The condition(s) this trial relates to.

Depression insomnia major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression - major depressive disorder Insomnia

Contacts and locations

Locations

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.