Clinical trial NCT04262557: Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome
Official title: Evaluation of the Correlation Between the Respiratory Index Events Generated by Sunrise® Versus Polysomnography for Sleep Apnea Syndrome Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome, Obstructive
Keywords: New medical device
Mandibular movement
Respiratory event index
Polysomnography
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Sunrise
name: Icadom
name: DOCAPOST
First posted: 2020-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: The performance of Sunrise® to detect the respiratory event index (REI)
timeFrame: 1 night
Secondary outcomes:
measure: Evaluation of the Sunrise® reproductibility on three consecutive nights
timeFrame: 3 nights
measure: Evaluation of the sleep quality: depth of sleep
timeFrame: 3 nights
measure: Evaluation of the sleep quality: number of wake-ups
timeFrame: 3 nights
measure: Evaluation of the sleep quality: sleep duration
timeFrame: 3 nights
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble Alpes
Study officials:
affiliation: University Hospital Grenoble Alpes
name: Jean Louis Pépin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.