Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531876
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Study of Dreem 3S to Evaluate Continuous Wake and Sleep Monitoring for the Diagnosis and Treatment Monitoring of Narcolepsy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 sleepnap duration and consolidatednon-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 OLZOLV PSG devices product codes for home sleep staging in patients with disturbed 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 OLZOLV PSG devices product codes for home sleep staging in patients with disturbed sleep
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None