WithdrawnNot Applicable

Feasibility Study of At-Home EEG Monitoring for Hypersomnia

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

0Started 2023-02

Plain-language 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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measuring sleep and wake events for the evaluation of hypersomnia disorders

Timeframe: 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

Timeframe: 2 days

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

Timeframe: 3 weeks

Trial details

NCT IDNCT05627388

SponsorKaiser Permanente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

View on ClinicalTrials.gov More Hypersomnia trials