Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-17 @ 9:14 PM
Study NCT ID:
NCT04262557
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Evaluation of the Correlation Between the Respiratory Index Events Generated by Sunrise® Versus Polysomnography for Sleep Apnea Syndrome Diagnosis
Status:
COMPLETED
Status Verified Date:
2020-10
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:
SENSAPNEA
Brief Summary:
Sleep Apnea Syndrome (SAS) is a serious health issue that should be managed in order to limit its adverse health consequences. SAS is known to induce cardiovascular diseases, diabetes and depression. The prevalence of SAS is still growing with social and economic repercussion. Today, polysomnography (PSG) is the gold standard reference method for SAS diagnosis. However, it is a constraining and expensive technology. In order to improve patients' life quality, many new technologies have been developed for the SAS diagnosis.
The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS diagnosis, in comparison with PSG. This solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (ERI) through an artificial intelligence algorithm analysis.
The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS diagnosis, in comparison with PSG. This solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (ERI) through an artificial intelligence algorithm analysis.
Detailed Description:
Sunrise® is a type IIa medical device with the CE label. It is a new home sleep technology, non-invasive, reliable and affordable by the patient.
The objective of this study is to evaluate the efficiency of the device in comparison with PSG for sleep apnea diagnosis.
40 subjects, suspected to be apneic, will be equipped at home by the chin sensor, the Sunrise® device, recording their mandibular movements while sleeping. The Sunrise® solution will provide the respiratory event index (REI) as well as the respiratory micro-arousals.
Inclusion visit will be executed at the University Hospital Grenoble Alpes. However, PSG and Sunrise® will be set at the patient's home by IC@dom. The first night, the patient will be equipped by both PSG and Sunrise® and only by the Sunrise® for the two following nights.
The objective of this study is to evaluate the efficiency of the device in comparison with PSG for sleep apnea diagnosis.
40 subjects, suspected to be apneic, will be equipped at home by the chin sensor, the Sunrise® device, recording their mandibular movements while sleeping. The Sunrise® solution will provide the respiratory event index (REI) as well as the respiratory micro-arousals.
Inclusion visit will be executed at the University Hospital Grenoble Alpes. However, PSG and Sunrise® will be set at the patient's home by IC@dom. The first night, the patient will be equipped by both PSG and Sunrise® and only by the Sunrise® for the two following nights.
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?: