Narcolepsy Type 1NCT06531876
Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
An observational study of Narcolepsy Type 1 and Hypersomnia, run by Beacon Biosignals at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy Type 1, Hypersomnia, Sleep Disorder
- What is being tested?
- Dreem 3S recording
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosed Narcolepsy or suspected Narcolepsy
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Intrepid Research
Cincinnati, Ohio, 45245
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335
Stanford University
Redwood City, California, 94063
Sleep Insights Medical Associates PLLC
Rochester, New York, 14623
About this study
Official title: 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.
Read the 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.
- Conditions
- Narcolepsy Type 1, Hypersomnia, Sleep Disorder
- Being tested
- Dreem 3S recording
- Medical subject headings
- Disorders of Excessive Somnolence, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dreem 3S recordingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Dreem 3S recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Days 9-10 (est)
Secondary outcomes (5)
Usability
Subject assessment of usability of the Dreem device, as measured by the System Usability Scale
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 9-10 (est)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Jul 2024
- Primary completion27 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beacon Biosignals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente, Stanford University, Intrepid Research, Sleep Insights, Sleep Management Institute
- Responsible party
- Sponsor
- Investigators
- Dennis Hwang, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531876
- Sponsor's protocol ID
- D3KAH
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Identifiable participant data will not be shared. Only deidentified data will be shared (EEG data, and related sleep metrics).
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Dreem 3S to Evaluate Continuous Wake and Sleep Monitoring for the Diagnosis and Treatment Monitoring of Narcolepsy.
- ClinicalTrials.gov ID
- NCT06531876
- Acronym / sponsor ID
- D3KAH
- Conditions
- Narcolepsy Type 1, Hypersomnia, Sleep Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Beacon BiosignalsIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente, Stanford University, Intrepid Research, Sleep Insights, Sleep Management Institute
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected Hypersomnia Arm [Arm A] | – | Device: Dreem 3S recordingSubjects 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] | – | Device: Dreem 3S recordingSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed Narcolepsy or suspected Narcolepsy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dreem 3S recordingSubjects 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. | Device | Known Narcolepsy Type 1 Arm [Arm B], Suspected Hypersomnia Arm [Arm A] |
Primary outcome
Compliance with Dreem 3S
Time frame: 1 week
The primary outcome of this study is the ability of subjects with hypersomnia to utilize the Dreem 3S system over multiple nights.
Consensus sleep staging
Time frame: 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).
5 secondary outcomes
Usability
Time frame: Days 1-7
24-hour usability
Time frame: Day 7 (est)
Detailed comparison between adjudicated Dreem derived sleep stages and PSG derived sleep stages
Time frame: Days 9-10 (est)
Comparison of Dreem derived hypnogram based sleep metrics with in-lab PSG
Time frame: Days 9-10 (est)
Agreement of Dreem derived sleep stages to PSG derived sleep stages
Time frame: Days 9-10 (est)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. Identifiable participant data will not be shared. Only deidentified data will be shared (EEG data, and related sleep metrics).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Hwang, MD principal investigator
Kaiser Permanente
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy Type 1 and Hypersomnia, run by Beacon Biosignals at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with Dreem 3S (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.