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

Ki vehet részt

• 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

Ki nem vehet részt

• 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 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 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 under 18 years old
• 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