Real-World Performance and Safety of Apneal Dx for Sleep Apnea Screening

NCT07809633 | Not Yet Recruiting

• 2 other identifiers: CIP042234417
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Keywords

post-market clinical follow-up; real-world evidence; smartphone; software as a medical device; screening; apnea-hypopnea index; digital health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Time to consultation

  Up to 24 months after the first recording

• Time to diagnosis

  Up to 24 months after the first recording

• Time to treatment

  Up to 24 months after the first recording

• Distribution of clinical decisions following the Apneal report

  Up to 24 months after the first recording

• Agreement with PSG and with ventilatory polygraphy

  Up to 24 months after the first recording

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Under 18 years of age
• Adult under legal protection

Sponsors & Collaborators

• Mitral: lead

Study Sites (1)

Mitral SAS

Charenton-le-Pont, 94220, France

Location

Related Publications (1)

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

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Guillaume Cathelain

  Mitral SAS

  STUDY DIRECTOR

Central Study Contacts

Guillaume Cathelain

CONTACT

+33672448711; guillaume.cathelain@apneal.ai

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)