Evaluation of a Wearable Sleep Monitoring Platform With Acoustic Stimulation for Mood Regulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Proportion of Participants Completing at Least 15 Usable Home Sleep-Recording Nights
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Wearable EEG-Based Sleep Monitoring and Closed-Loop Auditory Stimulation System (Device)
结局指标
主要结局
Proportion of Participants Completing at Least 15 Usable Home Sleep-Recording Nights
时间窗: 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%.
次要结局
- Automated Sleep-Stage Classification Accuracy(During home device use, up to 12 weeks)
- Closed-Loop Auditory Stimulation Delivery Success Rate(During home device use, up to 12 weeks)
- Number of Attempted Wearable-Device Nights per Participant(From enrollment through the end of home use, up to 12 weeks)
- Smartphone Assessment Completion Rate(From enrollment through the end of home use, up to 12 weeks)
- Number of Participants With Device- or Procedure-Related Adverse Events(From first device use through study exit, up to 12 weeks)
- Percentage of Recorded Sleep Epochs Meeting EEG Signal-Quality Criteria(During home device use, up to 12 weeks)
研究者
Ali Yousefi
Associate Professor
University of Houston