Evaluating a home sleep monitor for diagnosing narcolepsy
A Study of Dreem 3S to Evaluate Continuous Wake and Sleep Monitoring for the Diagnosis and Treatment Monitoring of Narcolepsy
This study is testing a new home sleep monitor to see if it can help diagnose narcolepsy and other sleep disorders more effectively than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beacon Biosignals Industry-sponsored |
| Locations | 4 sites (Fontana, California and 3 other locations) |
| Trial ID | NCT06531876 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of the Dreem 3S, an EEG-based sleep monitoring device, in diagnosing and evaluating narcolepsy type 1 and other hypersomnia disorders. It aims to provide a more natural and continuous assessment of sleep and wakefulness over multiple days, addressing the challenges of current diagnostic methods. The study will measure usability, patient compliance, and the accuracy of sleep staging compared to traditional sleep studies. Participants will use the device at home while undergoing standard diagnostic tests.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for a Multiple Sleep Latency Test (MSLT) to evaluate hypersomnia.
Not a fit: Patients under 18 years old or those unable to temporarily discontinue wake-promoting medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of narcolepsy and other hypersomnia disorders.
How similar studies have performed: Other studies have shown promise in using home sleep monitoring devices for sleep disorders, but this specific approach with the Dreem 3S is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fontana, California and 3 other locations
- Kaiser Permanente Fontana Medical Center — Fontana, California, United States (Recruiting)
- Stanford University — Redwood City, California, United States (Not_yet_recruiting)
- Sleep Insights Medical Associates PLLC — Rochester, New York, United States (Recruiting)
- Intrepid Research — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Dennis Hwang, MD — Kaiser Permanente
- Study coordinator: Jay Pathmanathan, MD, PhD
- Email: Jay.pathmanathan@beacon.bio
- Phone: 617-544-7284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.