Status:
ACTIVE_NOT_RECRUITING
Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
Lead Sponsor:
Beacon Biosignals
Collaborating Sponsors:
Kaiser Permanente
Stanford University
Conditions:
Narcolepsy Type 1
Hypersomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Diagnosing hypersomnia conditions (including narcolepsy type 1 \[NT1\], narcolepsy type 2 \[NT2\], and idiopathic hypersomnia \[IH\]) and differentiating them from other conditions is often challengin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06531876
Start Date
July 1 2024
End Date
December 1 2025
Last Update
October 1 2025
Active Locations (4)
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1
Kaiser Permanente Fontana Medical Center
Fontana, California, United States, 92335
2
Stanford University
Redwood City, California, United States, 94063
3
Sleep Insights Medical Associates PLLC
Rochester, New York, United States, 14623
4
Intrepid Research
Cincinnati, Ohio, United States, 45245