An observational study in Obstructive Sleep Apnea, Sleep Apnea Syndromes and Sleep Apnea, Obstructive, sponsored by Mitral. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Mitral · Observational
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Among 201 studies in Sleep Apnea, Obstructive with a site in France — 39 open to participants now, 48 under way, 4 of them phase 3. Sleep Apnea, Obstructive · France.
Among the 201 studies in Sleep Apnea, Obstructive with a site in France, this one is the 10th largest by planned enrollment of the 67 observational ones that give a count, is one of 14 that started in 2026, is one of 67 observational ones, reaches primary completion later than 46 of the 47 other live ones, and was the 199th registered.
2,242 studies on the registry are indexed under Sleep Apnea, Obstructive; 474 are open to participants now.
Browse Sleep Apnea, Obstructive studies →39 of the 201 studies in Sleep Apnea, Obstructive with a site in France are open now. Recruiting first, the newest first:
University Hospital, Grenoble · Sites in France
Ages 18–75
Hospices Civils de Lyon · Sites in France
Ages 4–17
University Hospital, Grenoble · Sites in France
Ages 18–85
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18–84
Hospices Civils de Lyon · Sites in France
Ages 5 mo–6 mo
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
201 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 14 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Median enrollment 52 across the 133 interventional studies, 140 across the 67 observational. Of the 121 that completed or were terminated, 6 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
38 of 201 have an industry lead sponsor. The 10 most frequent:
Mitral is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Mitral has 1 study filed under Sleep Apnea, Obstructive — fewer than ten, so there is no comparison to draw.
13 of the studies in Sleep Apnea, Obstructive with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07225686Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy | 2027-08-20 |
| NCT07226765Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy | 2027-08-30 |
| NCT07283289Centre Hospitalier Intercommunal de Toulon La Seyne sur MerPrevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive Disease | 2026-11 |
| NCT05939934University Hospital, AngersImpact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal | 2026-11 |
| NCT07792746Clinique du MillenaireSleep Apnea Biomarkers and Adherence to Continuous Positive Airway Pressure | 2026-12-31 |
Add all 13 to your calendar (.ics) → With an account.
Among the 201 studies in Sleep Apnea, Obstructive with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Both exclusion criteria are applied by design through an application eligibility rule.
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.
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)
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 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.
Time frame: Up to 24 months after the first recording, per participant
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 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.
Time frame: Up to 24 months after the first recording
Time to treatment
Median number of days between the reference sleep test and treatment initiation.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 6 months after the first recording
Plan to share: No
Start is estimated for Sep 2026; primary completion for Jun 2031, 57 months later.
Of 36 industry-sponsored observational studies under Sleep Apnea, Obstructive, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 93. This study's planned 57 months is above that.
Counting every sponsor, half of 294 studies reached it within 28 months; a quarter within 14 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Mitral