ACTIVE_NOT_RECRUITING

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

Conditions

Narcolepsy Type 1 Hypersomnia Sleep Disorder

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-01

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06531876

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Dennis Hwang, MD

PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Study Locations (Sites)

Kaiser Permanente Fontana Medical Center

Fontana, California, 92335

United States

Stanford University

Redwood City, California, 94063

United States

Sleep Insights Medical Associates PLLC

Rochester, New York, 14623

United States

Intrepid Research

Cincinnati, Ohio, 45245

United States

Collaborators and Investigators

Sponsor: Beacon Biosignals

Dennis Hwang, MD, PRINCIPAL_INVESTIGATOR, Kaiser Permanente

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-07-01

Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

Narcolepsy Type 1
Hypersomnia
Sleep Disorder