Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy

Launched by BEACON BIOSIGNALS · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a device called the Dreem 3S, which is designed to monitor sleep at home. The focus is on helping to diagnose and evaluate narcolepsy, particularly Narcolepsy Type 1, a condition that causes excessive sleepiness. Participants in this study will use the Dreem 3S along with other sleep tests to see how well the device works in identifying sleep disorders.

To be eligible for this trial, participants must be at least 18 years old and scheduled for a specific sleep test called the MSLT (Multiple Sleep Latency Test). They should be willing to use the Dreem 3S device and undergo other sleep monitoring as part of the study. However, individuals with certain medical conditions, those who are currently taking wake-promoting medications, or those who work unusual hours may not qualify. Participants can expect to have their sleep patterns monitored and will be closely guided throughout the process to ensure their safety and comfort.

Gender

ALL

Eligibility criteria

• 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 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.