Clinical trial NCT05057975: Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis
Official title: Validation d'Une Solution Digitale intégrée (SUNrise®) d'Analyse Automatique Des Mouvements Mandibulaires Par Intelligence Artificielle Versus Polysomnographie Pour le Diagnostic du Syndrome d'Apnées Obstructives du Sommeil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: polysomnography
obstructive sleep apnea
home sleep test
artificial intelligence
mandibular movement
Lead sponsor: Sunrise
Sponsor class: INDUSTRY
Collaborators: name: ICUREsearch
First posted: 2021-09-27
Enrollment: 848
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled, randomized, parrallel, open label, multicenter and national
Primary purpose: DIAGNOSTIC

Brief summary: Validation of an integrated digital solution (SUNrise®) of mandibular movement automatic analysis by artificial intelligence versus polysomnography for obstructive sleep apnea diagnosis: a prospective, randomized, parallel-arm, open-label, multicenter, national, controlled study.

Detailed description: The new Sunrise integrated digital solution is a disposable 3 gram sensor that sits on the chin for sleep disorders diagnosis. This device records mandibular movements, head movements and position during sleep. Data acquisition is done through a mobile application installed on the user smartphone. Data is then transferred automatically at the end of the test (overnight) to a cloud platform where it is automatically analyzed. The Health Care Professional (HCP) and the patient have access to sleep parameters and report.

The objective of this trial is to determine the place of the Sunrise device in the care pathway in France for patients suspected of having OSA. The assumption is that Sunrise is both non-inferior to the normal practice (i.e., the PSG) on sleepiness at 3 months post-diagnosis, and superior to the PSG (outpatient or in-lab) in terms of time between inclusion and diagnosis appointment and treatment initiation. By speeding up the treatment initiation, the hypothesis is that Sunrise is also superior to the PSG on sleepiness as well as quality of life and work productivity at 3 months post-inclusion. Another assumption is that Sunrise is non-inferior to the PSG on CPAP compliance at 3 months following treatment initiation.

The SUNSAS study will be launched in 19 centers (public and private) in France and will include 848 patients aged 18 to 80 years. Eligible patients will be included and randomized in 2 arms, i.e., the Sunrise arm and the PSG arm. An appointment to discuss the diagnosis and treatment options (for patients suffering from OSA) will be arranged after the procedure (PSG or Sunrise) is performed. On site follow-up visits will be then organized at 3 months post-inclusion and at 3 months post-diagnosis, and a phone call will be scheduled at 3 months post-treatment.

Eligibility criteria: Inclusion criteria:

* Man or woman aged between 18 to 80 years old
* Patient referred for a suspicion of OSA
* Patient having a smartphone and internet connection at home and able to use a mobile application
* Patient affiliated to the social security system

Main exclusion criteria:

* Patient with a previous sleep test performed within 5 years of inclusion
* Patient previously treated for OSA within 5 years of inclusion
* Patient suffering from severe chronic obstructive or restrictive pulmonary disease with or without oxygen at the discretion of the investigator
* Patient refusing to shave his beard that could prevent him to wear the device on the chin

Primary outcomes:
measure: Change in daily sleepiness
timeFrame: 3 months post-diagnosis
measure: Time to diagnosis
timeFrame: Up to 12 months
measure: Time to treatment
timeFrame: Up to 15 months
measure: Change in daily sleepiness
timeFrame: 3 months post inclusion
Secondary outcomes:
measure: Change in quality of life
timeFrame: 3 months post inclusion visit
measure: Change in quality of life
timeFrame: 3 months post inclusion visit
measure: Change in work productivity
timeFrame: 3 months post-inclusion
measure: cost (€)/QALY
timeFrame: 3 months post-diagnosis
measure: Net profit for the French social security
timeFrame: estimated at 3 years
measure: Comparison of CPAP compliance data
timeFrame: 3 month after treatment initiation
measure: Comparison of Sunrise versus PSG diagnosis
timeFrame: Up to 12 months
measure: Difference in the obstructive respiratory disturbance index (ORDI)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bobigny,
country: France
facility: Hôpitaux Universitaires de Paris Seine Saint-Denis (HUPSSD, AP-HP),
city: Bordeaux
country: France
facility: Nouvelle clinique Bel-Air
city: Bordeaux
country: France
facility: CHU Bordeaux - Hôpital Pellegrin
city: Créteil
country: France
facility: AP-HP Hôpital Henri Mondor
city: Grenoble
country: France
facility: Chu Grenoble Alpes,
city: Lille
country: France
facility: CHRU Lille - Hôpital Roger Salengro
city: Lille
country: France
facility: Hôpital privé la Louvière
city: Lyon
country: France
facility: CHU Lyon - Hôpital de la Croix-Rousse
city: Marseille
country: France
facility: Hôpital Européen Marseille
city: Montpellier
country: France
facility: CHU Montpellier - Hôpital Gui-de-Chauliac
city: Nancy
country: France
facility: CHRU de Nancy - Hôpital d'Adultes de Brabois
city: Paris
country: France
facility: AP-HP Pitié Salpêtrière
city: Paris
country: France
facility: AP-HP Hôpital Bichat-Claude Bernard
city: Paris
country: France
facility: AP-HP CUP Hôpital Hôtel Dieu
city: Reims
country: France
facility: CHU de Reims - Hôpital Maison Blanche
city: Rennes
country: France
facility: Polyclinique Saint-Laurent
city: Saint-Martin-d'Hères
country: France
facility: Centre du Sommeil de Grenoble
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Larrey
Study officials:
affiliation: CHU Grenoble Alpes
name: Jean-Louis PEPIN, Pr
role: PRINCIPAL_INVESTIGATOR
References: