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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Hypersomnia; Narcolepsy Type 1
• Intervention / Treatment: Device: Dreem 3S recording

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fontana, California, United States, 92335
      • Kaiser Permanente Fontana Medical Center
    • Redwood City, California, United States, 94063
      • Stanford University
  • New York
    • Rochester, New York, United States, 14623
      • Sleep Insights Medical Associates PLLC
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Intrepid Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed Narcolepsy or suspected Narcolepsy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected Hypersomnia Arm [Arm A]; Subjects being evaluated for a hypersomnia condition at participating sleep clinics will be recruited to Arm A. These subjects will not yet have a diagnosis and not yet be on treatment. These subjects will undergo 1 week of at-home ambulatory monitoring with the Dreem Headband, followed by formal in-lab evaluation with gold-standard polysomnography/multiple sleep latency testing while also using the Dreem Headband.	Device: Dreem 3S recording; Subjects in both Arms A and B will undergo at-home recording with the Dreem 3S EEG Headband to assess sleep. Subjects will undergo in-lab polysomnography and multiple sleep latency testing while also wearing the Dreem 3S EEG headband system. Arm B participants will be asked to withdraw from some or all of their Narcolepsy related medication therapy for roughly 19 days in order to assess the ability of the Dreem Headband System in characterizing sleep disturbances related to Narcolepsy.
Known Narcolepsy Type 1 Arm [Arm B]; Subjects with known Narcolepsy Type 1, under treatment at participating sleep clinics, will be recruited to Arm B. These subjects will be asked to withdraw from their Narcolepsy related medication therapy starting on day -7, undergo 1 week of at-home ambulatory monitoring with the Dreem Headband on days 1-7, and then undergo two consecutive nights of in-lab PSG followed by MSLT while synchronously using the Dreem headband.	Device: Dreem 3S recording; Subjects in both Arms A and B will undergo at-home recording with the Dreem 3S EEG Headband to assess sleep. Subjects will undergo in-lab polysomnography and multiple sleep latency testing while also wearing the Dreem 3S EEG headband system. Arm B participants will be asked to withdraw from some or all of their Narcolepsy related medication therapy for roughly 19 days in order to assess the ability of the Dreem Headband System in characterizing sleep disturbances related to Narcolepsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with Dreem 3S	The primary outcome of this study is the ability of subjects with hypersomnia to utilize the Dreem 3S system over multiple nights.	1 week
Consensus sleep staging	Positive percent agreement (PPA) for WAKE stage for human adjudicated automated sleep staging from the Dreem 3S data (test method) as compared to consensus human sleep staging of synchronouslly recorded PSG data (reference method).	Days 9-10 (est)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Subject assessment of usability of the Dreem device, as measured by the System Usability Scale	Days 1-7
24-hour usability	Percent of a 24 hour period during which subjects will be asked to wear and operate the Dreem 3S Headband device during which interpretable data is collected.	Day 7 (est)
Detailed comparison between adjudicated Dreem derived sleep stages and PSG derived sleep stages	Examination of Positive Predictive Agreement (PPA) for REM, N1, N2, N3 when comparing adjudicated labels derived from Dreem 3S recorded EEG and sleep stages from human adjudicated PSG data.	Days 9-10 (est)
Comparison of Dreem derived hypnogram based sleep metrics with in-lab PSG	Percentage of REM in the first 120 minutes of the night (starting after unambiguous sleep onset) will be compared from human adjudicated Dreem sleep labels and human adjudicated PSG data.	Days 9-10 (est)
Agreement of Dreem derived sleep stages to PSG derived sleep stages	Cohen's kappa of agreement will be calculated between human adjudicated automated sleep staging of Dreem 3S data and manual consensus sleep staging of PSG data collected during in-lab nocturnal monitoring.	Days 9-10 (est)

Collaborators and Investigators

• Sponsor: Beacon Biosignals
• Collaborators: Stanford University; Kaiser Permanente; Intrepid Research; Sleep Insights; Sleep Management Institute
• Investigators: Principal Investigator: Dennis Hwang, MD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): February 27, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Wake Disorders; Disorders of Excessive Somnolence
• Other Study ID Numbers: D3KAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Identifiable participant data will not be shared. Only deidentified data will be shared (EEG data, and related sleep metrics).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No