CompletedNo phase
Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis
Key facts
- Who runs it
- Sunrise
- Where
- France19 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 848 people enrolled
- Started
- 28 Oct 2021
- Ended
- 7 Oct 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Sunrise
- polysomnography
- Record updated
- 6 December 2024
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- SunriseTreatment being tested
Home Sleep Test, OSA diagnosis based on mandibular movements recording
- PSGExisting treatment, for comparison
Polysomnography, OSA diagnosis based on local scoring by center
Treatment: polysomnography
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 6 December 2024