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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Under 18 years of age
* Adult under legal protection
Both exclusion criteria are applied by design through an application eligibility rule.
Primary outcome measure(s)
Patient recording success rate — Continuous, from study start through study completion (up to 57 months) Proportion of interpretable nights among all attempted recordings, derived from automatic device logging.
Concordance between Apneal Dx severity category and the physician's final clinical diagnosis — Up to 24 months after the first recording, per participant Weighted Cohen's kappa and proportion of exact agreement between the AHI severity category produced by Apneal Dx (normal, mild, moderate, severe) and the final clinical diagnosis reported by the healthcare professional, in participants with a documented reference test (PSG or PG) obtained through routine care.
Real-world false positive and false negative rates by AHI threshold — Up to 24 months after the first recording, per participant False positive and false negative rates at AHI thresholds of 5, 15 and 30 events per hour, against the documented reference test result, with 95% Wilson confidence intervals.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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