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Device

Sleep Monitoring Device for Narcolepsy

N/A

Recruiting

Led By Dennis Hwang, MD

Research Sponsored by Beacon Biosignals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥ 18 years old

Be older than 18 years old

Must not have

Patients with a history of stroke or epilepsy

Patients unable to sign an informed consent form or have a legal guardian who can sign along with the patient's assent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 9-10 (est)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a device that can be used at home to monitor brain activity during sleep. The goal is to see if this device can help diagnose and assess sleep disorders, particularly Narcolepsy

Who is the study for?

This trial is for individuals experiencing excessive daytime sleepiness and suspect they might have Narcolepsy Type 1. Participants should be willing to use the Dreem 3S device at home to monitor their sleep.

What is being tested?

The study is testing the effectiveness of the Dreem 3S, a wearable EEG-based device designed for home use, in diagnosing and evaluating narcolepsy-related sleep issues.

What are the potential side effects?

Since this trial involves using a non-invasive monitoring device, there are no direct side effects associated with medications or invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stroke or epilepsy in the past.

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I cannot sign the consent form myself but have someone who can on my behalf.

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I have sleep apnea and don't use my CPAP machine as recommended.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 9-10 (est)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 9-10 (est)

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 9-10 (est) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compliance with Dreem 3S

Consensus sleep staging

Secondary study objectives

24-hour usability

Agreement of Dreem derived sleep stages to PSG derived sleep stages

Comparison of Dreem derived hypnogram based sleep metrics with in-lab PSG

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Suspected Hypersomnia Arm [Arm A]Experimental Treatment1 Intervention

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.

Group II: Known Narcolepsy Type 1 Arm [Arm B]Experimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met