Feasibility Study of At-Home EEG Monitoring for Hypersomnia

NCT05627388 | Withdrawn

• 1 other identifier: Dreem
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypersomnia; Narcolepsy

Keywords

At-Home Sleep EEG-Based Monitoring; Dreem 3 System; Polysomnography (PSG); Multiple Sleep Latency Test (MSLT)

Outcome Measures

Primary Outcomes (3)

• Measuring sleep and wake events for the evaluation of hypersomnia disorders

  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

  2 weeks

• 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

  * 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).

  2 days

• Measuring Treatment Efficacy with At-home EEG Monitoring (Dreem 3 System)

  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

  3 weeks

Study Arms (1)

Dreem 3 System

OTHER

Other: Dreem 3 System At-Home Monitoring

Interventions

Dreem 3 System At-Home Monitoring OTHER

Patients will be asked to wear the Dreem 3 System and actigraphy devices at home. Research support staff will teach patients how set up the device beforehand. Patients will wear Dreem and actigraph for 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. Then, for an additional continuous 48hr measurement, patients will wear the Dreem and actigraph. The patient will be given 2 devices, as one device can record up to 24h of data continuously. Patients are not required to stay home during the 48hr testing period. However, patients will be instructed to refrain from participating in activities which may shift or require removal of Dreem. Patients who wish to remain home for the 48hr testing period should have adequate sustenance (i.e., groceries). Any caffeine and sleep medication intake will be logged by the patient in a sleep diary. If needed, patients will be given an off work order from work/school for the 48hr assessment.

Dreem 3 System

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Shift workers or patients working unusual hours will be excluded
• Patients not able to sign an informed consent form

Sponsors & Collaborators

• Kaiser Permanente: lead
• Dreem SAS: collaborator

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Narcolepsy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: November 25, 2022
• Study Start: February 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05