Feasibility Study of At-Home EEG Monitoring for Hypersomnia

Not Applicable

Withdrawn

• Conditions: Narcolepsy; Hypersomnia
• Interventions: Other: Dreem 3 System At-Home Monitoring

• Registration Number: NCT05627388
• Lead Sponsor: Kaiser Permanente

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-11-25
• Study Start: 2023-02
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dreem 3 System	Dreem 3 System At-Home Monitoring	-

Primary Outcome Measures

Name	Time	Method
Measuring sleep and wake events for the evaluation of hypersomnia disorders	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	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)	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