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Feasibility Study of At-Home EEG Monitoring for Hypersomnia

Reason given: Study was never started. The research protocol was redeveloped and submitted as a new study therefore we would like to close this study.

Trial details

Who runs it
Kaiser Permanente
Trial code
NCT05627388
Record updated
14 May 2024
Original description
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.Read full original descriptionShow less

Feasibility Study of Utilizing At-Home Electroencephalography Monitoring for Diagnosing and Treatment Monitoring of Hypersomnia

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.

Inclusion: 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: 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); Patients under 6 years old; Shift workers or patients working unusual hours will be excluded; Patients not able to sign an informed consent form.

ClinicalTrials.gov NCT05627388