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

Sunrise

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Sunrise; Device: polysomnography

Study type: Interventional

Funder types: Industry

Identifiers

NCT05057975

PRO-545

Details and patient eligibility

About

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.

Full 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.

Enrollment: 848 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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848 participants in 2 patient groups

Sunrise

Experimental group

Description:

Home Sleep Test, OSA diagnosis based on mandibular movements recording

Treatment:

Device: Sunrise

PSG

Active Comparator group

Description:

Polysomnography, OSA diagnosis based on local scoring by center

Treatment:

Device: polysomnography