Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-11 @ 1:06 PM
Study NCT ID:
NCT03823105
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
Sponsor:
Insel Gruppe AG, University Hospital Bern
Organization:
Study Overview
Official Title:
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages: a Prospective, Method-comparison, Proof of Concept, Single-centre Phase IV Study
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.
Detailed Description:
The objective of this study is to evaluate and optimize a method of detecting sleep and sleep stages based on a new algorithm combining actigraphy and heart rate variability (measured by optical analysis of the pulse wave) to determine sleep architecture (segmented into three phases: WAKE, REM and NREM) with high accuracy compared to the gold standard polysomnography.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: