Feasibility Study of Utilizing At-Home Electroencephalography Monitoring for Diagnosing and Treatment Monitoring of Hypersomnia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Measuring sleep and wake events for the evaluation of hypersomnia disorders
研究概览
简要总结
The central hypothesis is that home EEG monitoring (Dream 3 wearable) can be feasibly utilized for data capture of continuous sleep and wake measurements for the diagnostic evaluation and treatment monitoring of hypersomnia.
详细描述
This clinical study is a prospective, single group assessment which will enroll patients who are prescribed a multiple sleep latency test (MSLT) at the Fontana Medical Sleep Center. Patients will be mailed an actigraph and a Dreem 3 system to undergo the following assessments:
- 1 initial in-person sleep physician encounter to discuss your sleep symptoms and review the informed consent form
- 1 week of actigraphy and Dreem 3 System monitoring. Actigraphy will be continuously monitored for 1 week to log sleep and wake periods. Dreem 3 System will be monitored for the first 5 nights and the last 2 days will be 48-hour continuous monitoring (i.e., day and night). Additionally, we will ask you to log your sleep/wake activity in a sleep diary.
- 2 consecutive in-lab sleep studies within a 24-hour period
- A few reminder telephone calls for at-home monitoring
Patients will have a follow up encounter with a physician after their in-lab visit. If a diagnosis is confirmed and treatment is initiated, the patient will be asked if they want to pursue treatment follow-up for the study. Again, patient will wear the Dreem 3 System and the actigraph during 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. Then, for an additional continuous 48 hour measurement, patients will wear the Dreem 3 system and actigraph (i.e. monitoring day and night). This procedure will occur once treatment is initiated as well as 1 month and 3 months after treatment initiation.
Patients will be asked to complete various sleep and quality of life questionnaires throughout the duration of the study. Questionnaires should take approximately 10-15 minutes to complete.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be a Kaiser Permanente member
- •Patients must be ≥ 6 years old.
- •Patients must have an indication for Multiple Sleep Latency Test for a diagnosis of hypersomnia
- •Patients are able/willing to consent and willing to undergo the electrophysiological routine assessments described in the protocol
- •Patients do not meet any exclusion criteria
排除标准
- •Patients under 6 years old.
- •If a patient is taking a wake promoting medication and is unsafe to withdraw the medication during the 2 weeks prior to the in-lab Polysomnography/Multiple Sleep Latency study
- •Patients suffering from mental and/or physical disorders that could interfere with the study protocol or the interpretation of the results (exclusion based on clinical judgment)
- •Shift workers or patients working unusual hours will be excluded
- •Patients not able to sign an informed consent form
结局指标
主要结局
Measuring sleep and wake events for the evaluation of hypersomnia disorders
时间窗: 2 weeks
Evaluating feasibility, quality, \& patient compliance of Dreem monitoring. The following aggregated metrics will produce an environment similar to standard care procedures for assessing hypersomnia in order to evaluate the monitoring capabilities of Dreem and actigraphy devices. * Usability Questionnaires: means, standard deviations, frequencies, \& scores * Number, type \& structure of sleep events as automatically determined by Dreem/Actigraphy devices, which are considered relevant for the initial evaluation of hypersomnia disorders by the physician * Dreem compliance: median/mean hours of usage over 24 hrs * % of Dreem records which pass the quality control criteria
Performance of the automatic scoring of the Dreem 3 compared to the consensus of 5 certified sleep scorers realized on the polysomnography, during PSG and MSLT
时间窗: 2 days
* Epoch by Epoch sleep stage scoring will be analyzed by generating the 5x5 confusion matrix between Dreem automatic sleep scoring and the 5 sleep scorers' consensus rating. * The stability and correlation of each sleep variable will be examined graphically and using intraclass correlation coefficients (ICC) with 95% confidence intervals (95% CI).
Measuring Treatment Efficacy with At-home EEG Monitoring (Dreem 3 System)
时间窗: 3 weeks
Evaluating feasibility, quality, \& patient compliance of Dreem monitoring after treatment initiation,1 month \& 3 months. The following aggregated metrics will produce an environment similar to standard care procedures for assessing hypersomnia in order to evaluate the treatment efficacy with the Dreem device. * Clinical \& QoL PRO: Mean change from baseline in ESS/NSS/IHSS/FOSQ10/EQ5D5L * Usability Questionnaires: means, standard deviations, frequencies, \& scores * Number, type \& structure of sleep events as automatically determined by Dreem/Actigraphy devices, which are considered relevant for the treatment efficacy evaluation of hypersomnia by the physician * Dreem compliance: median/mean hours of usage over 24 hrs * % of Dreem records which pass the quality control criteria
次要结局
未报告次要终点
研究者
Dennis Hwang, MD
Medical Director
Kaiser Permanente