Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis

Obstructive Sleep Apnea Clinical Trial

— SUNSAS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05057975
• Other study ID #: PRO-545
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 28, 2021
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Sunrise
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 848
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Sunrise
Use of the Sunrise device for three nights to register mandibular movements that will be automatically analysed using artificial intelligence.
• polysomnography
Reference protocol to diagnose OSA (in-lab or outpatient PSG)

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Hôpitaux Universitaires de Paris Seine Saint-Denis (HUPSSD, AP-HP),	Bobigny,
France	CHU Bordeaux - Hôpital Pellegrin	Bordeaux
France	Nouvelle clinique Bel-Air	Bordeaux
France	AP-HP Hôpital Henri Mondor	Créteil
France	Chu Grenoble Alpes,	Grenoble
France	CHRU Lille - Hôpital Roger Salengro	Lille
France	Hôpital privé la Louvière	Lille
France	CHU Lyon - Hôpital de la Croix-Rousse	Lyon
France	Hôpital Européen Marseille	Marseille
France	CHU Montpellier - Hôpital Gui-de-Chauliac	Montpellier
France	CHRU de Nancy - Hôpital d'Adultes de Brabois	Nancy
France	AP-HP CUP Hôpital Hôtel Dieu	Paris
France	AP-HP Hôpital Bichat-Claude Bernard	Paris
France	AP-HP Pitié Salpêtrière	Paris
France	CHU de Reims - Hôpital Maison Blanche	Reims
France	Polyclinique Saint-Laurent	Rennes
France	Centre du Sommeil de Grenoble	Saint-Martin-d'Hères
France	CHU de Toulouse - Hôpital Larrey	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Sunrise	ICUREsearch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in daily sleepiness	To determine the non-inferiority of Sunrise vs PSG on sleepiness at 3 months post-diagnosis using the Epworth Sleepiness Scale (ESS) score.; The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher the average sleep propensity in daily life.	3 months post-diagnosis
Primary	Time to diagnosis	To determine the superiority of Sunrise vs PSG in terms of time between inclusion and diagnosis appointment	Up to 12 months
Primary	Time to treatment	To determine the superiority of Sunrise vs PSG in terms of time between inclusion and treatment initiation	Up to 15 months
Primary	Change in daily sleepiness	To determine the superiority of Sunrise vs PSG on sleepiness at 3 months post-inclusion using ESS	3 months post inclusion
Secondary	Change in quality of life	To determine the superiority of Sunrise vs PSG on quality of life at 3 months post-inclusion using Short Form 36 (SF-36) SF-36 is a 0-100 scale score, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	3 months post inclusion visit
Secondary	Change in quality of life	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.	3 months post inclusion visit
Secondary	Change in work productivity	To determine the superiority of Sunrise vs PSG on work productivity at 3 months post-inclusion using WPAI:SHP	3 months post-inclusion
Secondary	cost (€)/QALY	cost (€)/QALY gained 3 months post-diagnosis	3 months post-diagnosis
Secondary	Net profit for the French social security	Estimation of the net profit for the French social security at 3 years	estimated at 3 years
Secondary	Comparison of CPAP compliance data	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	3 month after treatment initiation
Secondary	Comparison of Sunrise versus PSG diagnosis	To confirm the diagnosis performance of Sunrise compared to PSG by comparing the obstructive respiratory disturbance index (ORDI) in both groups	Up to 12 months
Secondary	Difference in the obstructive respiratory disturbance index (ORDI)	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)	Up to 12 months