Real-World Performance and Safety of Apneal Dx for Sleep Apnea Screening (APNEAL-PMCF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Obstructive Sleep Apnea

Detailed Description

OBJECTIVES

This PMCF study addresses residual evidence gaps after CE marking of Apneal Dx, under MDR Articles 61(11), 83, 84 and 86 and Annex XIV Part B, in support of a strategy based on Article 61(10).

Primary objectives:

(A) Demonstrate end-to-end technical performance in the unsupervised home environment and detect safety-relevant failure modes.

(B) Confirm concordance between the Apneal Dx AHI severity category and the healthcare professional's final clinical diagnosis obtained through the routine care pathway.

(C) Quantify real-world false positive and false negative rates at AHI thresholds of 5, 15 and 30 events per hour.

Secondary objectives:

(D) Care-pathway time indicators (time to consultation, diagnosis and treatment).

(E) How device outputs are used in clinical decisions. (F) Diagnostic performance against polysomnography (PSG) and ventilatory polygraphy (PG), when those tests have already been performed in routine care.

(G) Real-world screening utility, conditions of use and usability.

METHODS

Design: observational, prospective, single-cohort, longitudinal real-world data collection. Non-comparative; no randomisation; no blinding; no imposed follow-up visit. Target enrolment: 400 evaluable patients (estimated). Individual participation lasts up to 24 months (questionnaires at 6, 12 and 24 months after the first recording). Study period: 04 September 2026 to 10 June 2031 (57 months, aligned with the CE certificate cycle).

No intervention is assigned by the protocol. Apneal Dx is used under normal conditions of use and within its intended purpose. A PSG or PG result is collected only if the test has already been performed in the usual care pathway; the study never prescribes, prompts, schedules or funds a confirmatory test.

Data sources: (1) automatic technical metadata from the device (session duration, signal quality, processing events, error codes, software version); (2) healthcare professional questionnaire (H01-H14) on the HCP web platform; (3) patient questionnaire (P01-P12) in the mobile application. No medical records, no SNDS, no biospecimens, no linkage with an external database.

Setting: home and routine clinical practice. Decentralised collection with no investigational site, no participating institution and no principal investigator. The sponsor headquarters (Mitral SAS, Charenton-le-Pont, France) is declared as the single administrative location. Participants may reside in France, Spain, Italy, the United Kingdom or Germany.

Ethics: no ethics committee is territorially or institutionally competent in the absence of a site. Human subjects protection review is therefore recorded as not required. Participation follows a dedicated in-app information notice, distinct from the terms of use, and a voluntary in-app agreement. A permanent right to object applies.

Analysis: descriptive (point estimates and 95% Wilson confidence intervals, distributions, weighted Cohen kappa for concordance, sensitivity and specificity by AHI threshold, median delays). No superiority or non-inferiority hypothesis test. No multiplicity adjustment. Missing data are not imputed.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Guillaume Cathelain; Phone Number: +33672448711; Email: guillaume.cathelain@apneal.ai

Study Locations

• France
  • Charenton-le-Pont, France, 94220
    • Mitral SAS
    • Contact: Guillaume Cathelain; Phone Number: +33672448711; Email: guillaume.cathelain@apneal.ai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Apneal Dx users; Adults aged 18 years or over with sleep complaints, using Apneal Dx within its intended purpose at home in routine care, who have completed at least one recording generating a night report.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient recording success rate	Proportion of interpretable nights among all attempted recordings, derived from automatic device logging.	Continuous, from study start through study completion (up to 57 months)
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.	Up to 24 months after the first recording, per participant
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.	Up to 24 months after the first recording, per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to consultation	Median number of days between the Apneal Dx night report and the first consultation with a healthcare professional.	Up to 24 months after the first recording
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.	Up to 24 months after the first recording
Time to treatment	Median number of days between the reference sleep test and treatment initiation.	Up to 24 months after the first recording
Distribution of clinical decisions following the Apneal report	Distribution of clinical decisions taken following the Apneal Dx report, by Apneal severity category.	Up to 24 months after the first recording
Agreement with PSG and with ventilatory polygraphy	Agreement of Apneal Dx with PSG and with ventilatory polygraphy, stratified by reference test type and severity, in participants with a documented routine-care reference test.	Up to 24 months after the first recording
Healthcare professional rating of Apneal Dx reliability	Proportion of healthcare professionals rating Apneal Dx as reliable (score 4 or 5 on a 1-5 Likert scale).	Up to 24 months after the first recording
Usability: navigation ease and instruction clarity	Distribution of navigation ease and instruction clarity scores (1-5 Likert scales) reported by patients.	6 months after the first recording

Collaborators and Investigators

• Sponsor: Mitral
• Investigators: Study Director: Guillaume Cathelain, Mitral SAS

Publications and helpful links

General Publications

• Evaluation of the Clinical Performance of Apneal, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis (EASY). ClinicalTrials.gov Identifier: NCT06474143.

Helpful Links

• Related clinical investigation EASY (NCT06474143): evaluation of Apneal clinical performance against polysomnography

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: September 3, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: smartphone; digital health; screening; software as a medical device; real-world evidence; apnea-hypopnea index; post-market clinical follow-up
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CIP04; 2234417 (Other Identifier: CNIL MR-004 compliance undertaking)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No