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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Sunrise; Device: polysomnography

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.

• Study Type: Interventional
• Enrollment (Actual): 848
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU Angers
  • Bobigny,, France, 93000
    • Hôpitaux Universitaires de Paris Seine Saint-Denis (HUPSSD, AP-HP),
  • Bordeaux, France, 33073
    • Nouvelle Clinique Bel-Air
  • Bordeaux, France, 33076
    • CHU bordeaux - Hopital Pellegrin
  • Créteil, France, 94000
    • AP-HP Hopital Henri Mondor
  • Grenoble, France, 38043
    • Chu Grenoble Alpes,
  • Lille, France, 59037
    • CHRU Lille - Hôpital Roger Salengro
  • Lille, France, 59800
    • Hopital Prive La Louviere
  • Lyon, France, 69004
    • CHU Lyon - Hôpital de la Croix-Rousse
  • Marseille, France, 13003
    • Hôpital Européen Marseille
  • Montpellier, France, 34295
    • CHU Montpellier - Hôpital Gui-de-Chauliac
  • Nancy, France, 54500
    • CHRU de Nancy - Hôpital d'Adultes de Brabois
  • Paris, France, 75013
    • AP-HP Pitié Salpetrière
  • Paris, France, 75018
    • AP-HP Hopital Bichat-Claude Bernard
  • Paris, France, 75181
    • AP-HP CUP Hôpital Hôtel Dieu
  • Reims, France, 51092
    • CHU de Reims - Hôpital Maison Blanche
  • Rennes, France, 35700
    • Polyclinique Saint-Laurent
  • Saint-Martin-d'Hères, France, 38400
    • Centre du Sommeil de Grenoble
  • Toulouse, France, 31059
    • CHU de Toulouse - Hôpital Larrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sunrise; Home Sleep Test, OSA diagnosis based on mandibular movements recording	Device: Sunrise; Use of the Sunrise device for three nights to register mandibular movements that will be automatically analysed using artificial intelligence.
Active Comparator: PSG; Polysomnography, OSA diagnosis based on local scoring by center	Device: polysomnography; Reference protocol to diagnose OSA (in-lab or outpatient PSG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to diagnosis	To determine the superiority of Sunrise vs PSG in terms of time between inclusion and diagnosis appointment	Up to 12 months
Time to treatment	To determine the superiority of Sunrise vs PSG in terms of time between inclusion and treatment initiation	Up to 15 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
cost (€)/QALY	cost (€)/QALY gained 3 months post-diagnosis	3 months post-diagnosis
Net profit for the French social security	Estimation of the net profit for the French social security at 3 years	estimated at 3 years
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
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
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

Collaborators and Investigators

• Sponsor: Sunrise
• Collaborators: ICUREsearch
• Investigators: Principal Investigator: Jean-Louis PEPIN, Pr, Chu Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Actual): October 7, 2024
• Study Completion (Actual): October 7, 2024

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: polysomnography; obstructive sleep apnea; artificial intelligence; home sleep test; mandibular movement
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: PRO-545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No