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

NCT05057975 | Completed

• 1 other identifier: PRO-545
• Study Type: interventional
• Target: 848
• Locations: 1 country
• Sites: 19

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.

Conditions

Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Change in quality of life

  3 months post inclusion visit

• Change in quality of life

  3 months post inclusion visit

• Change in work productivity

  3 months post-inclusion

• cost (€)/QALY

  3 months post-diagnosis

• Net profit for the French social security

  estimated at 3 years

Study Arms (2)

Sunrise

EXPERIMENTAL

Home Sleep Test, OSA diagnosis based on mandibular movements recording

Device: Sunrise

PSG

ACTIVE COMPARATOR

Polysomnography, OSA diagnosis based on local scoring by center

Device: polysomnography

Interventions

Sunrise DEVICE

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

Sunrise

polysomnography DEVICE

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

PSG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunrise: lead
• ICUREsearch: collaborator

Study Sites (19)

CHU Angers

Angers, 49933, France

Location

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

Bobigny, 93000, France

Location

Nouvelle clinique Bel-Air

Bordeaux, 33073, France

Location

CHU Bordeaux - Hôpital Pellegrin

Bordeaux, 33076, France

Location

AP-HP Hôpital Henri Mondor

Créteil, 94000, France

Location

Chu Grenoble Alpes,

Grenoble, 38043, France

Location

CHRU Lille - Hôpital Roger Salengro

Lille, 59037, France

Location

Hôpital privé la Louvière

Lille, 59800, France

Location

CHU Lyon - Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Hôpital Européen Marseille

Marseille, 13003, France

Location

CHU Montpellier - Hôpital Gui-de-Chauliac

Montpellier, 34295, France

Location

CHRU de Nancy - Hôpital d'Adultes de Brabois

Nancy, 54500, France

Location

AP-HP Pitié Salpêtrière

Paris, 75013, France

Location

AP-HP Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

AP-HP CUP Hôpital Hôtel Dieu

Paris, 75181, France

Location

CHU de Reims - Hôpital Maison Blanche

Reims, 51092, France

Location

Polyclinique Saint-Laurent

Rennes, 35700, France

Location

Centre du Sommeil de Grenoble

Saint-Martin-d'Hères, 38400, France

Location

CHU de Toulouse - Hôpital Larrey

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jean-Louis PEPIN, Pr

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, controlled, randomized, parrallel, open label, multicenter and national

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 27, 2021
• Study Start: October 28, 2021
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (19)