Improving CPAP adherence through patient involvement in telemonitoring

Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP

This study is testing whether letting patients help manage their CPAP treatment alerts through telemonitoring can improve how well they stick to using the device for sleep apnea.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 556 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Asten Sante (industry)
• Locations: 11 sites (La Roche-sur-Yon, France and 10 other locations)
• Trial ID: NCT05960175 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of patient involvement in managing alerts during telemonitoring of Continuous Positive Airway Pressure (CPAP) treatment for obstructive sleep apnea (OSA). It compares standard telemonitoring by healthcare providers with a new approach where patients use connected devices to monitor their health and report alerts. The study consists of an initial four-month interventional phase followed by an observational phase lasting up to twelve months. All participants will use the same CPAP device, and their adherence will be closely monitored to assess the effectiveness of the different telemonitoring approaches.

Who should consider this trial

Good fit: Ideal candidates are adults with newly diagnosed OSA, low sleepiness, and at least one cardiovascular risk factor.

Not a fit: Patients already using CPAP, those with unstable health conditions, or cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve CPAP adherence and overall treatment outcomes for patients with OSA.

How similar studies have performed: Previous studies have shown promising results with telemonitoring approaches, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* Adult with newly diagnosed OSA (with central apnea index \<5 ev/h), justifying CPAP and with low sleepiness (Epworth score \<11 at inclusion).
* Patient with at least 1 cardiovascular risk factor (obesity, type I or II diabetes with or without treatment, permanent hypertension with or without treatment, heart failure with preserved ejection fraction, valve disease, history of atrial fibrillation, history of ischaemic heart disease, history of stroke).
* Patient with a smartphone and who agrees to use connected objects during the study.
* Signed informed consent form,
* Subject affiliated to a health insurance system, or is a beneficiary.

Exclusion Criteria:

* Patients already fitted with a CPAP machine,
* Patients with permanent atrial fibrillation,
* Patients whose state of health is not stable or requires heavy treatment,
* Patients with cognitive problems.
* Patients participating in another intervention research in pulmonology.
* Vulnerable subject

Where this trial is running

La Roche-sur-Yon, France and 10 other locations

• CH Départemental Vendée — La Roche-sur-Yon, France, France (RECRUITING)
• AP-HP Hôpital Européen Georges — Paris, France, France (RECRUITING)
• CHU Angers - Service de pneumologie — Angers, France (RECRUITING)
• CHU Dijon-Bourgogne — Dijon, France (RECRUITING)
• CH Versailles — Le Chesnay, France (RECRUITING)
• CH Le Mans — Le Mans, France (RECRUITING)
• CHU Nancy — Nancy, France (RECRUITING)
• AP-HP Pitié Salpêtrière — Paris, France (RECRUITING)
• AP-HP Bichat Claude Bernard — Paris, France (RECRUITING)
• Polyclinique Saint-Laurent - Groupe médical de pneumologie — Rennes, France (RECRUITING)
• CHU Rouen - Charles Nicolle — Rouen, France (RECRUITING)

Study contacts

• Principal investigator: Arnaud Prigent, Dr — Polyclinique Saint-Laurent
• Study coordinator: Anne-Laure Sérandour

Conditions: OSA, Cheyne-Stokes respiration, Continuous positive airway pressure, Telemedicine