SleepNCT07808645
Wearable Sleep EEG and Auditory Stimulation in Healthy Adults
A study testing Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation System in people with Sleep and Healthy Vollunteer, run by University of Houston.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Healthy Vollunteer
- What is being tested?
- Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2027to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep, Healthy Vollunteer
- Being tested
- Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation System
- Keywords
- Wearable EEG, Closed-Loop Auditory Stimulation, Sleep Monitoring, Home-Based Sleep Monitoring, Sleep-Stage Detection, Slow-Wave Activity, Delta Sleep Ratio, Device Feasibility, Electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Wearable EEG Monitoring and Closed-Loop Auditory Stimulation | Experimental | 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. Receives: Device: Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Completing at Least 15 Usable Home Sleep-Recording Nights
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%.
Measured: From initiation of home use through the end of the home-use period, up to 12 weeks
Secondary outcomes (6)
Automated Sleep-Stage Classification Accuracy
Percentage of sleep epochs correctly classified against reference labels, with balanced accuracy, sensitivity, specificity, precision, recall, F1 score, and Cohen's kappa also reported.
Measured: During home device use, up to 12 weeks
Closed-Loop Auditory Stimulation Delivery Success Rate
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.
Measured: During home device use, up to 12 weeks
Number of Attempted Wearable-Device Nights per Participant
Number of nights on which each participant attempts wearable-device use, regardless of whether the resulting recording meets the usable-night criteria.
Measured: From enrollment through the end of home use, up to 12 weeks
Smartphone Assessment Completion Rate
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.
Measured: From enrollment through the end of home use, up to 12 weeks
Number of Participants With Device- or Procedure-Related Adverse Events
Number and percentage of participants with device- or procedure-related adverse events, including skin irritation, discomfort, sleep disruption, device malfunction, or app problems.
Measured: From first device use through study exit, up to 12 weeks
Percentage of Recorded Sleep Epochs Meeting EEG Signal-Quality Criteria
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.
Measured: During home device use, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Apr 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will complete the same single-group home-use protocol involving wearable EEG sleep monitoring, study-configured closed-loop auditory stimulation, and smartphone-based assessments. Participants will not be assigned to separate comparison groups.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Yousefi, University of Houston
- Investigators
- Ali Yousefi, Ph.D., Principal investigator, University of Houston, Houston, TX, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808645
- Sponsor's protocol ID
- STUDY00005659
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Wearable Sleep Monitoring Platform With Acoustic Stimulation for Mood Regulation
- ClinicalTrials.gov ID
- NCT07808645
- Acronym / sponsor ID
- STUDY00005659
- Conditions
- Sleep, Healthy Vollunteer
- Keywords
- Wearable EEG, Closed-Loop Auditory Stimulation, Sleep Monitoring, Home-Based Sleep Monitoring, Sleep-Stage Detection, Slow-Wave Activity, Delta Sleep Ratio, Device Feasibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will complete the same single-group home-use protocol involving wearable EEG sleep monitoring, study-configured closed-loop auditory stimulation, and smartphone-based assessments. Participants will not be assigned to separate comparison groups.
| Arm | Type | Receives |
|---|---|---|
| Wearable EEG Monitoring and Closed-Loop Auditory Stimulation | Experimental | Device: Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation SystemParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation SystemAn 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. | Device | Wearable EEG Monitoring and Closed-Loop Auditory Stimulation |
Primary outcome
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%.
6 secondary outcomes
Automated Sleep-Stage Classification Accuracy
Time frame: 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
Number of Attempted Wearable-Device Nights per Participant
Time frame: 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
Number of Participants With Device- or Procedure-Related Adverse Events
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Yousefi, Ph.D. principal investigator
University of Houston, Houston, TX, United States
Questions about this trial
What is this clinical trial studying?
A study testing Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation System in people with Sleep and Healthy Vollunteer, run by University of Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Yousefi, Ph.D. (713-743-3745, aliyousefi@uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.