NCT04262557

Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome

Evaluation of the Correlation Between the Respiratory Index Events Generated by Sunrise® Versus Polysomnography for Sleep Apnea Syndrome Diagnosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Sleep Apnea Syndrome, Obstructive

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sunrise® solution	Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform.
DIAGNOSTIC_TEST	Polysomnography	Gold standard method to diagnose SAS used as comparator

Timeline

• Start date: 2020-05-18
• Primary completion: 2020-09-28
• Completion: 2020-09-28
• First posted: 2020-02-10
• Last updated: 2020-10-19

Locations

1 site across 1 country: France