Wearable Sleep EEG and Auditory Stimulation in Healthy Adults

September 1, 2026 updated by: Ali Yousefi, University of Houston

Evaluation of a Wearable Sleep Monitoring Platform With Acoustic Stimulation for Mood Regulation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will complete eligibility screening and provide written informed consent before beginning study procedures. At enrollment, University of Houston study personnel will provide training on placement and removal of the forehead sensor, use of the study smartphone and application, device handling and charging, reporting of discomfort or technical problems, and procedures for stopping device use.

Participants will use the wearable EEG-based sleep-monitoring system at home during natural sleep for up to 12 weeks, with a target of at least 15 usable nights of sleep data. The external, battery-powered, non-invasive system records EEG and device-session information, supports automated sleep-stage detection, and delivers brief, low-volume pink-noise sounds during selected stages of non-rapid eye movement sleep according to study-configured closed-loop timing parameters. The device does not deliver electrical stimulation to the participant. Device and auditory-stimulation settings will be configured by study personnel and will not be adjusted by participants.

During the home-use period, participants will complete smartphone-based assessments that include sleep-diary information, sleep quality, mood, stress, device feedback, and memory tasks. Study personnel will provide technical assistance and monitor device use, data quality, participant-reported discomfort, and device or application problems.

Study analyses will focus on home-use feasibility, completion of usable recording nights, participant adherence, EEG signal quality, automated sleep-stage classification, slow-wave activity, delta sleep ratio, auditory-stimulation timing and delivery performance, application completion, and safety and tolerability. Findings will be used to refine the wearable system, signal-processing algorithms, participant instructions, and study procedures before a later clinical assessment in adults with major depressive disorder.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Wearable EEG Monitoring and Closed-Loop Auditory Stimulation
Participants will use the investigational wearable EEG-based sleep-monitoring system at home during sleep for up to 12 weeks, targeting at least 15 usable nights of recording. The system records sleep EEG and device-session information and delivers brief, low-volume auditory stimulation according to study-configured closed-loop timing parameters. Participants will also complete smartphone-based sleep, mood, stress, device-feedback, and memory assessments.
Device: Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation System
An investigational, external, battery-powered, non-invasive forehead-worn system that records EEG during sleep, supports automated sleep-stage and slow-wave detection, and delivers brief, low-volume pink-noise sounds during selected stages of non-rapid eye movement sleep according to study-configured closed-loop timing parameters. The system does not deliver electrical stimulation to the participant. Device and stimulation settings are configured by study personnel.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Completing at Least 15 Usable Home Sleep-Recording Nights
Time Frame: From initiation of home use through the end of the home-use period, up to 12 weeks
Number of participants completing at least 15 usable nights divided by the number of enrolled participants who initiate home use. A usable night contains sufficient continuous wearable EEG and device-log data for the planned signal-processing and algorithmic stimulation-delivery analyses. The prespecified feasibility benchmark is greater than 75%.
From initiation of home use through the end of the home-use period, up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Automated Sleep-Stage Classification Accuracy
Time Frame: During home device use, up to 12 weeks
Percentage of sleep epochs correctly classified against reference labels, with balanced accuracy, sensitivity, specificity, precision, recall, F1 score, and Cohen's kappa also reported.
During home device use, up to 12 weeks
Closed-Loop Auditory Stimulation Delivery Success Rate
Time Frame: During home device use, up to 12 weeks
Percentage of algorithm-triggered auditory pulses successfully delivered and recorded within prespecified timing and latency limits. Device logs will also characterize missed events and alignment with targeted sleep-stage or slow-wave features.
During home device use, up to 12 weeks
Number of Attempted Wearable-Device Nights per Participant
Time Frame: From enrollment through the end of home use, up to 12 weeks
Number of nights on which each participant attempts wearable-device use, regardless of whether the resulting recording meets the usable-night criteria.
From enrollment through the end of home use, up to 12 weeks
Smartphone Assessment Completion Rate
Time Frame: From enrollment through the end of home use, up to 12 weeks
Percentage of scheduled smartphone-based sleep diary, sleep-quality, mood, stress, device-feedback, and study-task assessments completed by each participant during the home-use period.
From enrollment through the end of home use, up to 12 weeks
Number of Participants With Device- or Procedure-Related Adverse Events
Time Frame: From first device use through study exit, up to 12 weeks
Number and percentage of participants with device- or procedure-related adverse events, including skin irritation, discomfort, sleep disruption, device malfunction, or app problems.
From first device use through study exit, up to 12 weeks
Percentage of Recorded Sleep Epochs Meeting EEG Signal-Quality Criteria
Time Frame: During home device use, up to 12 weeks
Percentage of recorded sleep epochs meeting the prespecified signal-quality, signal-to-noise, and artifact-rejection criteria required for automated sleep-stage classification and estimation of slow-wave activity and delta sleep ratio.
During home device use, up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali Yousefi, Ph.D., University of Houston, Houston, TX, United States

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00005659

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the reported study results may be shared with qualified researchers, consistent with participant consent and subject to applicable IRB, institutional, data-use, and privacy requirements. Direct identifiers and the participant-code linkage file will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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