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Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy

NCT06531876 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Dreem 3S recording

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.

Sponsors & Collaborators

  • Kaiser Permanente

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Intrepid Research

    collaborator UNKNOWN

  • Sleep Insights

    collaborator INDUSTRY

  • Sleep Management Institute

    collaborator UNKNOWN

  • Beacon Biosignals

    lead INDUSTRY

Principal Investigators

  • Dennis Hwang, MD · Kaiser Permanente

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-02-27
Completion
2026-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06531876 on ClinicalTrials.gov