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Feasibility Study of At-Home EEG Monitoring for Hypersomnia

NCT05627388 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-05-14

No results posted yet for this study

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

Interventions

OTHER

Dreem 3 System At-Home Monitoring

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.

Sponsors & Collaborators

  • Dreem SAS

    collaborator UNKNOWN

  • Kaiser Permanente

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-04-01
Completion
2024-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05627388 on ClinicalTrials.gov