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

Sponsor

Sunrise (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05057975

Collaborator

ICUREsearch (Industry)

848

Enrollment

Locations

Arms

28.1

Anticipated Duration (Months)

60.6

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: Sunrise Device: polysomnography	N/A

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 14 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 Design

Study Type:

Interventional

Anticipated Enrollment :

848 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, controlled, randomized, parrallel, open label, multicenter and nationalProspective, controlled, randomized, parrallel, open label, multicenter and national

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Oct 28, 2021

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Change in daily sleepiness [3 months post-diagnosis]
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.
Time to diagnosis [Up to 12 months]
To determine the superiority of Sunrise vs PSG in terms of time between inclusion and diagnosis appointment
Time to treatment [Up to 15 months]
To determine the superiority of Sunrise vs PSG in terms of time between inclusion and treatment initiation
Change in daily sleepiness [3 months post inclusion]
To determine the superiority of Sunrise vs PSG on sleepiness at 3 months post-inclusion using ESS

Secondary Outcome Measures

Change in quality of life [3 months post inclusion visit]
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.
Change in quality of life [3 months post inclusion visit]
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.
Change in work productivity [3 months post-inclusion]
To determine the superiority of Sunrise vs PSG on work productivity at 3 months post-inclusion using WPAI:SHP
cost (€)/QALY [3 months post-diagnosis]
cost (€)/QALY gained 3 months post-diagnosis
Net profit for the French social security [estimated at 3 years]
Estimation of the net profit for the French social security at 3 years
Comparison of CPAP compliance data [3 month after treatment initiation]
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
Comparison of Sunrise versus PSG diagnosis [Up to 12 months]
To confirm the diagnosis performance of Sunrise compared to PSG by comparing the obstructive respiratory disturbance index (ORDI) in both groups
Difference in the obstructive respiratory disturbance index (ORDI) [Up to 12 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Angers	Angers	France	49933
2	Hôpitaux Universitaires de Paris Seine Saint-Denis (HUPSSD, AP-HP),	Bobigny,	France	93000
3	Nouvelle clinique Bel-Air	Bordeaux	France	33073
4	CHU Bordeaux - Hôpital Pellegrin	Bordeaux	France	33076
5	AP-HP Hôpital Henri Mondor	Créteil	France	94000
6	Chu Grenoble Alpes,	Grenoble	France	38043
7	CHRU Lille - Hôpital Roger Salengro	Lille	France	59037
8	Hôpital privé la Louvière	Lille	France	59800
9	CHU Lyon - Hôpital de la Croix-Rousse	Lyon	France	69004
10	Hôpital Européen Marseille	Marseille	France	13003
11	CHU Montpellier - Hôpital Gui-de-Chauliac	Montpellier	France	34295
12	AP-HP Hôpital Bichat-Claude Bernard	Paris	France	75018
13	AP-HP CUP Hôpital Hôtel Dieu	Paris	France	75181
14	Polyclinique Saint-Laurent	Rennes	France	35700