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

NCT06531876 | Completed FDA Device

• 1 other identifier: D3KAH
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Narcolepsy Type 1; Hypersomnia; Sleep Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Usability

  Days 1-7

• 24-hour usability

  Day 7 (est)

• Detailed comparison between adjudicated Dreem derived sleep stages and PSG derived sleep stages

  Days 9-10 (est)

• Comparison of Dreem derived hypnogram based sleep metrics with in-lab PSG

  Days 9-10 (est)

• Agreement of Dreem derived sleep stages to PSG derived sleep stages

  Days 9-10 (est)

Study Arms (2)

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

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

Interventions

Dreem 3S recording DEVICE

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]; Suspected Hypersomnia Arm [Arm A]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed Narcolepsy or suspected Narcolepsy

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beacon Biosignals: lead
• Kaiser Permanente: collaborator
• Stanford University: collaborator
• Intrepid Research: collaborator
• Sleep Insights: collaborator
• Sleep Management Institute: collaborator

Study Sites (4)

Kaiser Permanente Fontana Medical Center

Fontana, California, 92335, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

Sleep Insights Medical Associates PLLC

Rochester, New York, 14623, United States

Location

Intrepid Research

Cincinnati, Ohio, 45245, United States

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis Hwang, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: July 1, 2024
• Primary Completion: February 27, 2026
• Study Completion: March 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)