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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05057975
Other study ID # PRO-545
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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