Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: SunriseDevice: polysomnography
- Registration Number
- NCT05057975
- Lead Sponsor
- Sunrise
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 848
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sunrise Sunrise Home Sleep Test, OSA diagnosis based on mandibular movements recording PSG polysomnography Polysomnography, OSA diagnosis based on local scoring by center
- Primary Outcome Measures
Name Time Method Time to treatment Up to 15 months To determine the superiority of Sunrise vs PSG in terms of time between inclusion and treatment initiation
Change in daily sleepiness 3 months post inclusion To determine the superiority of Sunrise vs PSG on sleepiness at 3 months post-inclusion using ESS
Time to diagnosis Up to 12 months To determine the superiority of Sunrise vs PSG in terms of time between inclusion and diagnosis appointment
- Secondary Outcome Measures
Name Time Method Comparison of Sunrise versus PSG diagnosis Up to 12 months To confirm the diagnosis performance of Sunrise compared to PSG by comparing the obstructive respiratory disturbance index (ORDI) in both groups
Change in quality of life 3 months post inclusion visit To determine the superiority of Sunrise vs PSG on quality of life at 3 months post-inclusion using Quebec Sleep Questionnaire (QSQ).
QSQ utilizes 32 items to measure 5 domains: daytime sleepiness, diurnal symptoms, nocturnal symptoms, emotions, and social interactions.Item scores range from 1 to 7. Mean scores for each domain are calculated, and a total score is derived by calculating the mean of all items. Higher scores are associated with better better quality of life.cost (€)/QALY 3 months post-diagnosis cost (€)/QALY gained 3 months post-diagnosis
Change in work productivity 3 months post-inclusion To determine the superiority of Sunrise vs PSG on work productivity at 3 months post-inclusion using WPAI:SHP
Net profit for the French social security estimated at 3 years Estimation of the net profit for the French social security at 3 years
Comparison of CPAP compliance data 3 month after treatment initiation To determine the non-inferiority of Sunrise vs PSG on CPAP compliance measured at 3 months post-treatment by comparing CPAP average usage in both groups
Difference in the obstructive respiratory disturbance index (ORDI) Up to 12 months To measure the variability of the ORDI by comparing the 3 obstructive respiratory disturbance index (ORDI) measures provided by the Sunrise device (used 3 nights)
Trial Locations
- Locations (19)
CHU de Reims - Hôpital Maison Blanche
🇫🇷Reims, France
Hôpitaux Universitaires de Paris Seine Saint-Denis (HUPSSD, AP-HP),
🇫🇷Bobigny,, France
CHU Angers
🇫🇷Angers, France
Nouvelle clinique Bel-Air
🇫🇷Bordeaux, France
CHU Bordeaux - Hôpital Pellegrin
🇫🇷Bordeaux, France
Chu Grenoble Alpes,
🇫🇷Grenoble, France
AP-HP Hôpital Henri Mondor
🇫🇷Créteil, France
CHRU Lille - Hôpital Roger Salengro
🇫🇷Lille, France
Hôpital Européen Marseille
🇫🇷Marseille, France
CHU Lyon - Hôpital de la Croix-Rousse
🇫🇷Lyon, France
Hôpital privé la Louvière
🇫🇷Lille, France
CHU Montpellier - Hôpital Gui-de-Chauliac
🇫🇷Montpellier, France
CHRU de Nancy - Hôpital d'Adultes de Brabois
🇫🇷Nancy, France
AP-HP Pitié Salpêtrière
🇫🇷Paris, France
AP-HP Hôpital Bichat-Claude Bernard
🇫🇷Paris, France
Polyclinique Saint-Laurent
🇫🇷Rennes, France
AP-HP CUP Hôpital Hôtel Dieu
🇫🇷Paris, France
Centre du Sommeil de Grenoble
🇫🇷Saint-Martin-d'Hères, France
CHU de Toulouse - Hôpital Larrey
🇫🇷Toulouse, France