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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ali Yousefi, Ph.D.
- 電話番号：713-743-3745
- メール：aliyousefi@uh.edu
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Participants Completing at Least 15 Usable Home Sleep-Recording Nights
時間枠：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%.
|
From initiation of home use through the end of the home-use period, up to 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Automated Sleep-Stage Classification Accuracy
時間枠：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.
|
During home device use, up to 12 weeks
|
|
Closed-Loop Auditory Stimulation Delivery Success Rate
時間枠：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.
|
During home device use, up to 12 weeks
|
|
Number of Attempted Wearable-Device Nights per Participant
時間枠：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.
|
From enrollment through the end of home use, up to 12 weeks
|
|
Smartphone Assessment Completion Rate
時間枠：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.
|
From enrollment through the end of home use, up to 12 weeks
|
|
Number of Participants With Device- or Procedure-Related Adverse Events
時間枠：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.
|
From first device use through study exit, up to 12 weeks
|
|
Percentage of Recorded Sleep Epochs Meeting EEG Signal-Quality Criteria
時間枠：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.
|
During home device use, up to 12 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Ali Yousefi, Ph.D.、University of Houston, Houston, TX, United States
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- STUDY00005659
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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