An interventional study of Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation System in Sleep and Healthy Vollunteer, sponsored by University of Houston. Not yet recruiting. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of Houston · Not applicable, Interventional, and Other
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.
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.
University of Houston is the lead sponsor of 102 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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%.
Time frame: From initiation of home use through the end of the home-use period, up to 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During home device use, up to 12 weeks
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Apr 2027; primary completion for Jun 2028, 14 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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