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

Description

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.

Conditions

Narcolepsy Type 1, Hypersomnia, Sleep Disorder

Study Overview

Study Details

Study overview

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.

A Study of Dreem 3S to Evaluate Continuous Wake and Sleep Monitoring for the Diagnosis and Treatment Monitoring of Narcolepsy

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

Condition
Narcolepsy Type 1
Intervention / Treatment

-

Contacts and Locations

Fontana

Kaiser Permanente Fontana Medical Center, Fontana, California, United States, 92335

Redwood City

Stanford University, Redwood City, California, United States, 94063

Rochester

Sleep Insights Medical Associates PLLC, Rochester, New York, United States, 14623

Cincinnati

Intrepid Research, Cincinnati, Ohio, United States, 45245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Beacon Biosignals,

Dennis Hwang, MD, PRINCIPAL_INVESTIGATOR, Kaiser Permanente

Study Record Dates

2025-06-01