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Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome

NCT04262557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-10-19

No results posted yet for this study

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.

Conditions

  • Sleep Apnea Syndrome, Obstructive

Interventions

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

Sponsors & Collaborators

  • Sunrise

    collaborator INDUSTRY

  • Icadom

    collaborator INDUSTRY

  • DOCAPOST

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean Louis Pépin, MD, PhD · University Hospital Grenoble Alpes

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-18
Primary Completion
2020-09-28
Completion
2020-09-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262557 on ClinicalTrials.gov