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Evaluation of a wearable sleep monitoring platform with acoustic stimulation for mood regulation

NCT ID NCT07808645

NEW Sponsor: University of Houston Source: ClinicalTrials.gov ↗

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First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

The purpose of this single-site pilot study is to evaluate the feasibility, usability, and technical performance of a wearable sleep-monitoring system that records electroencephalography (EEG) and delivers brief, low-volume sounds during selected stages of sleep. Approximately 30 healthy adults aged 18 to 30 years will use the system at home for up to 12 weeks, with a target of at least 15 usable nights of sleep recording. Participants will also complete smartphone-based assessments of sleep, mood, stress, device experience, and memory. The study will evaluate home-use completion, EEG signal quality, automated sleep-stage detection, delivery of auditory stimulation, participant adherence, and safety and tolerability. This pilot study is intended to refine the device and study procedures and is not designed to determine whether the system treats depression or another medical condition.

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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.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2027

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

18 to 30 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age 18-30 years. * Able to provide independent written informed consent. * Able to read and speak English. * Generally healthy and maintains a regular sleep schedule. * Willing and able to use the wearable EEG system at home during sleep and complete smartphone-based assessments. * Adequate hearing to perceive the auditory stimulation. * Able to follow device-use, safety-reporting, and study procedures. Exclusion Criteria: * Diagnosed sleep disorder, including insomnia or sleep apnea. * Diagnosed psychiatric condition, including major depressive disorder or an anxiety disorder. * Neurological disorder, including epilepsy, seizure disorder, or significant traumatic brain injury. * Hearing impairment that would interfere with auditory stimulation. * Use of medication expected to substantially affect sleep, mood, or study outcomes, including sedative-hypnotic or relevant psychoactive medication. * Known allergy or sensitivity to device materials, adhesives, conductive materials, or other skin-contact components. * Current pregnancy. * Cognitive impairment or another condition preventing independent consent. Prisoner status. * Student or employee over whom the investigator or study personnel have direct grading, supervisory, employment, or evaluative authority. * Acute illness, dizziness, significant headache or earache, excessive fatigue, or another temporary safety or data-quality concern at the time of study procedures. Participation may be deferred or rescheduled when appropriate.

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Conditions

The condition(s) this trial relates to.

sleep disorder

As listed by the trial registrant

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

Healthy vollunteer Sleep

How to take part

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