Real-World Performance and Safety of Apneal Dx for Sleep Apnea Screening
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMitral
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Under 18 years of age
Adult under legal protection
Trial population
Adults with sleep complaints using the CE-marked Apneal Dx software as a medical device within its intended purpose, at home and in routine clinical practice, in France, Spain, Italy, Great Britain and Germany. The entire eligible active user base is solicited; no selection, sampling, stratification or quota is applied.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: Apneal Dx users
Trial outcomes
Primary outcomes
1
Patient recording success rate
Proportion of interpretable nights among all attempted recordings, derived from automatic device logging.
Time frame
Continuous, from study start through study completion (up to 57 months)2
Concordance between Apneal Dx severity category and the physician's final clinical diagnosis
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.
Time frame
Up to 24 months after the first recording, per participant3
Real-world false positive and false negative rates by AHI threshold
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.
Time frame
Up to 24 months after the first recording, per participantSecondary outcomes
1
Time to consultation
Median number of days between the Apneal Dx night report and the first consultation with a healthcare professional.
Time frame
Up to 24 months after the first recording2
Time to diagnosis
Median number of days between the Apneal Dx night report and the reference sleep test (PSG or PG) performed in routine care.
Time frame
Up to 24 months after the first recording3
Time to treatment
Median number of days between the reference sleep test and treatment initiation.
Time frame
Up to 24 months after the first recording4
Distribution of clinical decisions following the Apneal report
Distribution of clinical decisions taken following the Apneal Dx report, by Apneal severity category.
Time frame
Up to 24 months after the first recording Source ClinicalTrials.gov
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