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

Last updated: July 29, 2024
Sponsor: Beacon Biosignals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Restless Leg Syndrome

Sleep Disorders

Treatment

Dreem 3S recording

Clinical Study ID

NCT06531876
D3KAH
  • Ages > 18
  • All Genders

Study 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 Type 1.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must be ≥ 18 years old.

  • Patients must be scheduled for an MSLT for a potential diagnosis of hypersomnia (ArmA 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 medicationsas per protocol.

  • (for Known NT1 arm [Arm B] only) Agree to discontinue driving and operating heavymachinery while untreated for their condition and according to the PI's judgement.

Exclusion

Exclusion Criteria:

  • Patients under 18 years old.

  • If a patient is taking a wake promoting drug and is unsafe to temporarily reduce ordiscontinue the drug during the 2 weeks prior to nocturnal PSG and MSLT due to theiroccupation, need to drive or operate heavy machinery, role as a primary caretaker,medical risk of temporarily discontinuing from drug therapy, or any other reason atthe discretion of the subject's treating physician or study physicians/PIs.

  • Patients suffering from mental and/or physical disorders that could interfere withthe study protocol or the interpretation of the results (exclusion based on clinicaljudgment).

  • Shift workers or patients working unusual hours will be excluded. 5. Patients with ahistory of stroke or epilepsy.

  • Patients with an implanted hypoglossal nerve stimulator or a diagnosis of moderateto severe sleep apnea (Apnea-Hypopnea Index (AHI) 3% >15) not adherent on positiveairway 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 beeligible).

  • Patients who are unable to sign an informed consent form, or unable to have a legalguardian who is able to sign along with the patient's assent.

  • Patients who are deemed ineligible by the site PI or treating physician for anyother reason.

Study Design

Total Participants: 78
Treatment Group(s): 1
Primary Treatment: Dreem 3S recording
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
June 01, 2025

Study 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 challenging as symptoms including excessive daytime sleepiness, daytime napping, and disturbed nocturnal sleep are nonspecific and current diagnostic tests are limited. Unfortunately, patients with hypersomnia often demonstrate a discrepancy between self-reported sleep duration and quantitative assessment. This complicates both diagnosis and management, as objective sleep assessment is typically not available over multiple periods. A more natural approach would be to monitor sleep and wakefulness serially and with monitoring, including assessment of total sleep time, rapid eye movement (REM) latency, daytime sleep attacks, daytime sleep/nap duration, and consolidated/non-consolidated nocturnal sleep.

This validation study evaluates the ability of Dreem 3S to capture multiple days of continuous sleep and wake measures in subjects with hypersomnia, particularly in NT1. Primary outcomes will include usability of Dreem 3S by patients with hypersomnia, patient compliance with longitudinal data collection using Dreem 3S at-home, and fidelity of sleep staging of Dreem 3S data to synchronously recorded gold-standard nocturnal PSG and MSLT.

Dreem 3S is an FDA cleared class II medical device, under the OLZ/OLV (PSG devices) product codes for home sleep staging in patients with disturbed sleep.

Connect with a study center

  • Kaiser Permanente Fontana Medical Center

    Fontana, California 92335
    United States

    Active - Recruiting

  • Stanford University

    Redwood City, California 94063
    United States

    Site Not Available

  • Sleep Insights Medical Associates PLLC

    Rochester, New York 14623
    United States

    Active - Recruiting

  • Intrepid Research

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

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