NCT07808645|Not Yet RecruitingFDA Device
Wearable Sleep EEG and Auditory Stimulation in Healthy Adults
Evaluation of a Wearable Sleep Monitoring Platform With Acoustic Stimulation for Mood Regulation
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Evaluation of a Wearable Sleep Monitoring Platform With Acoustic Stimulation for Mood Regulation
Sponsor study identifier
interventional
30
0 countries
N/A
Study Start
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 29, 2026
Actual (reported)September 9, 2026
Actual (reported)April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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%.
From initiation of home use through the end of the home-use period, up to 12 weeks
Automated Sleep-Stage Classification Accuracy
During home device use, up to 12 weeks
Closed-Loop Auditory Stimulation Delivery Success Rate
During home device use, up to 12 weeks
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ali Yousefi, Ph.D.
University of Houston, Houston, TX, United States
First Submitted
August 29, 2026
First Posted
September 9, 2026
Study Start
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Impact of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2
Number of Attempted Wearable-Device Nights per Participant
From enrollment through the end of home use, up to 12 weeks
Smartphone Assessment Completion Rate
From enrollment through the end of home use, up to 12 weeks
Number of Participants With Device- or Procedure-Related Adverse Events
From first device use through study exit, up to 12 weeks
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 9, 2026
Record last verified: 2026-09
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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Source: ClinicalTrials.gov.
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