Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
Key facts
- Who runs it
- Beacon Biosignals
- Where
- Cincinnati, Fontana, Redwood City, and Rochester, United StatesSee the 4 sites
- Trial code
- Status
- Completed
- People taking part
- 78 people enrolled
- Started
- 1 Jul 2024
- Ended
- 1 Mar 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Dreem 3S recording
- Record updated
- 17 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 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 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 under 18 years old
- 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 in United States
- Intrepid ResearchCincinnati, United States
- Kaiser Permanente Fontana Medical CenterFontana, United States
- Stanford UniversityRedwood City, United States
- Sleep Insights Medical Associates PLLCRochester, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 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.
Treatment: 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.
Treatment: Dreem 3S recording
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Study of Dreem 3S to Evaluate Continuous Wake and Sleep Monitoring for the Diagnosis and Treatment Monitoring of Narcolepsy.
- Record updated
- 17 March 2026