Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
- Conditions
- Narcolepsy Type 1HypersomniaSleep Disorder
- Interventions
- Device: Dreem 3S recording
- Registration Number
- NCT06531876
- Lead Sponsor
- Beacon Biosignals
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Suspected Hypersomnia Arm [Arm A] Dreem 3S recording 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. Known Narcolepsy Type 1 Arm [Arm B] Dreem 3S recording 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.
- Primary Outcome Measures
Name Time Method Consensus sleep staging Days 9-10 (est) 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).
Compliance with Dreem 3S 1 week The primary outcome of this study is the ability of subjects with hypersomnia to utilize the Dreem 3S system over multiple nights.
- Secondary Outcome Measures
Name Time Method Detailed comparison between adjudicated Dreem derived sleep stages and PSG derived sleep stages Days 9-10 (est) 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.
Usability Days 1-7 Subject assessment of usability of the Dreem device, as measured by the System Usability Scale
24-hour usability Day 7 (est) 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.
Comparison of Dreem derived hypnogram based sleep metrics with in-lab PSG Days 9-10 (est) 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.
Agreement of Dreem derived sleep stages to PSG derived sleep stages Days 9-10 (est) 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.
Trial Locations
- Locations (4)
Intrepid Research
🇺🇸Cincinnati, Ohio, United States
Kaiser Permanente Fontana Medical Center
🇺🇸Fontana, California, United States
Stanford University
🇺🇸Redwood City, California, United States
Sleep Insights Medical Associates PLLC
🇺🇸Rochester, New York, United States