Healthy Vollunteer, Sleep
Conditions
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
Brief 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. 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.
Interventions
DEVICEWearable 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.
Sponsors
University of Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Completing at Least 15 Usable Home Sleep-Recording Nights | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Automated Sleep-Stage Classification Accuracy | 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. |
| Closed-Loop Auditory Stimulation Delivery Success Rate | 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. |
| Number of Attempted Wearable-Device Nights per Participant | 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. |
| Smartphone Assessment Completion Rate | 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. |
| Number of Participants With Device- or Procedure-Related Adverse Events | 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. |
| Percentage of Recorded Sleep Epochs Meeting EEG Signal-Quality Criteria | 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. |
Contacts
CONTACTAli Yousefi, Ph.D.
PRINCIPAL_INVESTIGATORAli Yousefi, Ph.D.
University of Houston, Houston, TX, United States
Outcome results
None listed