NCT06531876

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

A Study of Dreem 3S to Evaluate Continuous Wake and Sleep Monitoring for the Diagnosis and Treatment Monitoring of Narcolepsy.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: Beacon Biosignals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-02-27
• Completion: 2026-03-01
• First posted: 2024-08-01
• Last updated: 2026-03-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study