Real-World Performance and Safety of Apneal Dx for Sleep Apnea Screening
Key facts
- Where
- Charenton-le-Pont, FranceSee the site
Where in France
- Mitral SASCharenton-le-Pont, FranceContact: Guillaume CathelainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Mitral
- Trial code
- NCT07809633
- Record updated
- 9 September 2026
- Original description
Sleep apnea-hypopnea syndrome (SAHS) is a frequent and largely under-diagnosed sleep-related breathing disorder. Adult prevalence is estimated between 9% and 38%. Untreated SAHS increases cardiometabolic and neurocognitive risk. Reference diagnostic methods (in-lab polysomnography and ambulatory ventilatory polygraphy) have limited capacity, which delays care.Read full original descriptionShow less
Real-world Evaluation of the Clinical Performance and Safety of Apneal Dx for the Screening and Aid in the Diagnosis of Obstructive Sleep Apnea-hypopnea Syndrome in Adults: a Post-market Clinical Follow-up Study
Sleep apnea-hypopnea syndrome (SAHS) is a frequent and largely under-diagnosed sleep-related breathing disorder. Adult prevalence is estimated between 9% and 38%. Untreated SAHS increases cardiometabolic and neurocognitive risk. Reference diagnostic methods (in-lab polysomnography and ambulatory ventilatory polygraphy) have limited capacity, which delays care.
Apneal Dx is a Class IIa software as a medical device (CE-marked 10 June 2026). It measures cardiorespiratory sleep activity using the sensors of a standard smartphone worn on the chest, with no additional sensor, to screen for and aid in the diagnosis of adult obstructive sleep apnea-hypopnea syndrome at home.
This study is a non-interventional, prospective, real-world post-market clinical follow-up (PMCF) of Apneal Dx used within its intended purpose in routine care. It does not add any examination, visit, randomisation or change to patient management. Data are collected from automatic device logs and optional in-app questionnaires completed by patients and healthcare professionals. The study covers France, Spain, Italy, the United Kingdom and Germany. There is no investigational site and no principal investigator.
Inclusion: Aged 18 years or over; Uses Apneal Dx within its intended purpose in France, Spain, Italy, the United Kingdom or Germany; Has completed at least one recording generating a night report; Has received the study information notice; Has given the in-app agreement to take part.
Exclusion: Under 18 years of age; Adult under legal protection; Both exclusion criteria are applied by design through an application eligibility rule.