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

NCT ID: NCT05057975

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 848 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-28
• Study Completion Date: 2024-10-07

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.

Conditions

Obstructive Sleep Apnea

Keywords

polysomnography; obstructive sleep apnea; home sleep test; artificial intelligence; mandibular movement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sunrise

Home Sleep Test, OSA diagnosis based on mandibular movements recording

Group Type: EXPERIMENTAL

Sunrise

Intervention Type: DEVICE

Use of the Sunrise device for three nights to register mandibular movements that will be automatically analysed using artificial intelligence.

PSG

Polysomnography, OSA diagnosis based on local scoring by center

Group Type: ACTIVE_COMPARATOR

polysomnography

Intervention Type: DEVICE

Reference protocol to diagnose OSA (in-lab or outpatient PSG)

Interventions

Sunrise

Use of the Sunrise device for three nights to register mandibular movements that will be automatically analysed using artificial intelligence.

Intervention Type: DEVICE

polysomnography

Reference protocol to diagnose OSA (in-lab or outpatient PSG)

Intervention Type: DEVICE

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ICUREsearch

INDUSTRY

Sponsor Role: collaborator

Sunrise

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis PEPIN, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes

Locations

CHU Angers

Angers, , France

Hôpitaux Universitaires de Paris Seine Saint-Denis (HUPSSD, AP-HP),

Bobigny, , France

Nouvelle clinique Bel-Air

Bordeaux, , France

CHU Bordeaux - Hôpital Pellegrin

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 Pitié Salpêtrière

Paris, , France

AP-HP Hôpital Bichat-Claude Bernard

Paris, , France

AP-HP CUP Hôpital Hôtel Dieu

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, , France

Countries

France

Other Identifiers

PRO-545

Identifier Type: -

Identifier Source: org_study_id