Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
Completed
Conditions studied: Narcolepsy Type 1, Hypersomnia, Sleep Disorder
In brief
This study intends to examine the utility of a home-use EEG-based sleep monitor for the diagnosis and evaluation of disorders of excessive sleepiness, specifically the neurological disorder Narcolepsy Type 1.
Key facts
- Study ID
- NCT06531876
- Run by
- Beacon Biosignals
- People needed
- 78
- Starts
- 2024-07-01
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2026-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be ≥ 18 years old.
- Patients must be scheduled for an MSLT for a potential diagnosis of hypersomnia (Arm A only).
- Patients are able/willing to consent and willing to undergo the nocturnal PSG, MSLT, and Dreem 3S monitoring described in the protocol.
- (for Known NT1 arm [Arm B] only) Deemed safe to discontinue prohibited medications as per protocol.
- (for Known NT1 arm [Arm B] only) Agree to discontinue driving and operating heavy machinery while untreated for their condition and according to the PI's judgement.
You may not qualify if…
- Patients under 18 years old.
- If a patient is taking a wake promoting drug and is unsafe to temporarily reduce or discontinue the drug during the 2 weeks prior to nocturnal PSG and MSLT due to their occupation, need to drive or operate heavy machinery, role as a primary caretaker, medical risk of temporarily discontinuing from drug therapy, or any other reason at the discretion of the subject's treating physician or study physicians/PIs.
- 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. 5. Patients with a history of stroke or epilepsy.
- Patients with an implanted hypoglossal nerve stimulator or a diagnosis of moderate to severe sleep apnea (Apnea-Hypopnea Index (AHI) 3% >15) not adherent on positive airway pressure therapy (usage 30-day window prior to enrollment date reveals <70% days use at least hours; patients treated with non-PAP treatments will not be eligible).
- Patients who are unable to sign an informed consent form, or unable to have a legal guardian who is able to sign along with the patient's assent.
- Patients who are deemed ineligible by the site PI or treating physician for any other reason.
Where it is running
- Kaiser Permanente Fontana Medical Center — Fontana, California, United States
- Stanford University — Redwood City, California, United States
- Sleep Insights Medical Associates PLLC — Rochester, New York, United States
- Intrepid Research — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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