Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome

NCT ID: NCT04262557

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-18
• Study Completion Date: 2020-09-28

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sunrise+PSG

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.

Group Type: EXPERIMENTAL

Sunrise® solution

Intervention Type: DIAGNOSTIC_TEST

Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform.

Polysomnography

Intervention Type: DIAGNOSTIC_TEST

Gold standard method to diagnose SAS used as comparator

Interventions

Sunrise® solution

Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform.

Intervention Type: DIAGNOSTIC_TEST

Polysomnography

Gold standard method to diagnose SAS used as comparator

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

PSG

Eligibility Criteria

Inclusion Criteria

• Patients suspected to have a sleep apnea syndrome (Berlin score≥2)
• Able to use a smartphone application
• Be legally able to give consent
• Person affiliated to social security

Exclusion Criteria

• Patients already treated for SAS
• Patients suffering from a chronic obstructive or restrictive pulmonary disease with or without oxygen.
• Patients suffering from a unstable cardiovascular disease or a severe heart failure requiring an hospitalzation in the previous three months or conform with the New York Heart Association criteria for class II or III diseases
• Patients treated with myorelaxant medicines
• Patients with a long beard disabling the setting of the mandibular sensor
• Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.
• Person in exclusion period for another study or participating in a medical study testing drugs.
• Subjects not being cooperative or respecting the study instructions, according the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunrise

INDUSTRY

Sponsor Role: collaborator

Icadom

INDUSTRY

Sponsor Role: collaborator

DOCAPOST

UNKNOWN

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Louis Pépin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Grenoble Alpes

Locations

University Hospital Grenoble Alpes

Grenoble, , France

Countries

France

References

Kelly JL, Ben Messaoud R, Joyeux-Faure M, Terrail R, Tamisier R, Martinot JB, Le-Dong NN, Morrell MJ, Pepin JL. Diagnosis of Sleep Apnoea Using a Mandibular Monitor and Machine Learning Analysis: One-Night Agreement Compared to in-Home Polysomnography. Front Neurosci. 2022 Mar 15;16:726880. doi: 10.3389/fnins.2022.726880. eCollection 2022.

Reference Type: DERIVED

PMID: 35368281 (View on PubMed)

Other Identifiers

38RC19.358

Identifier Type: -

Identifier Source: org_study_id