Wearable Sleep EEG and Auditory Stimulation in Healthy Adults

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.

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.