Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome (SENSAPNEA)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Sleep Apnea Syndrome, Obstructive

Treatments: Diagnostic Test: Sunrise® solution; Diagnostic Test: Polysomnography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04262557

38RC19.358

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Sunrise+PSG

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Sunrise® solution

Diagnostic Test: Polysomnography