Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy (NCT06531876) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
United States78 participantsStarted 2024-07-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 ai…