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Could a headband replace the sleep lab? new study tests At-Home narcolepsy diagnosis

NCT ID NCT06531876

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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