Wearable Sleep EEG and Auditory Stimulation in Healthy Adults
Evaluation of a Wearable Sleep Monitoring Platform With Acoustic Stimulation for Mood Regulation
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ali Yousefi, Ph.D.
- Telefoonnummer: 713-743-3745
- E-mail: aliyousefi@uh.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Wearable EEG Monitoring and Closed-Loop Auditory Stimulation
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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Proportion of Participants Completing at Least 15 Usable Home Sleep-Recording Nights
Tijdsspanne: From initiation of home use through the end of the home-use period, up to 12 weeks
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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%.
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From initiation of home use through the end of the home-use period, up to 12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Automated Sleep-Stage Classification Accuracy
Tijdsspanne: During home device use, up to 12 weeks
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Percentage of sleep epochs correctly classified against reference labels, with balanced accuracy, sensitivity, specificity, precision, recall, F1 score, and Cohen's kappa also reported.
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During home device use, up to 12 weeks
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Closed-Loop Auditory Stimulation Delivery Success Rate
Tijdsspanne: During home device use, up to 12 weeks
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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.
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During home device use, up to 12 weeks
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Number of Attempted Wearable-Device Nights per Participant
Tijdsspanne: From enrollment through the end of home use, up to 12 weeks
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Number of nights on which each participant attempts wearable-device use, regardless of whether the resulting recording meets the usable-night criteria.
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From enrollment through the end of home use, up to 12 weeks
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Smartphone Assessment Completion Rate
Tijdsspanne: From enrollment through the end of home use, up to 12 weeks
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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.
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From enrollment through the end of home use, up to 12 weeks
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Number of Participants With Device- or Procedure-Related Adverse Events
Tijdsspanne: From first device use through study exit, up to 12 weeks
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Number and percentage of participants with device- or procedure-related adverse events, including skin irritation, discomfort, sleep disruption, device malfunction, or app problems.
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From first device use through study exit, up to 12 weeks
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Percentage of Recorded Sleep Epochs Meeting EEG Signal-Quality Criteria
Tijdsspanne: During home device use, up to 12 weeks
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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.
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During home device use, up to 12 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ali Yousefi, Ph.D., University of Houston, Houston, TX, United States
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- STUDY00005659
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