Could a headband replace the sleep lab? new study tests At-Home narcolepsy diagnosis
NCT ID NCT06531876
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a headband called Dreem 3S that people wear at home to monitor sleep and wake patterns. The goal was to see if it can help diagnose narcolepsy, a condition that causes extreme daytime sleepiness. 78 adults took part, and researchers checked how well the device worked compared to standard sleep lab tests.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
78 people
The number who actually took part.
- Started
-
Jul 2024
- Finished
-
Mar 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with diagnosed Narcolepsy or suspected Narcolepsy
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hypersomnia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Intrepid Research
Cincinnati, Ohio, 45245, United States
-
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335, United States
-
Sleep Insights Medical Associates PLLC
Rochester, New York, 14623, United States
-
Stanford University
Redwood City, California, 94063, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Awake but asleep: brain waves may explain crushing daytime sleepiness
- Writing as medicine: can words soothe chronic pain?
- Can a new pill tame Narcolepsy's sudden sleep and muscle weakness?
- A Drug-Free sleep fix for obese pregnant women? trial puts it to the test
- Do current sleepiness tests work for kids? a new study puts them to the test
- Fixing sleep, fortifying hearts: a new trial tests the link