Wearable Sleep EEG and Auditory Stimulation in Healthy Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of Houston
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation System
DeviceAn 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Wearable EEG Monitoring and Closed-Loop Auditory StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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