Clinical Trial

Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP

Active, Not Recruiting
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Summary
Adherence to CPAP determines the expected benefits of the treatment. A dose-benefit relationship has been demonstrated for both functional and cardiovascular benefits. The first few days' use of the device are decisive in determining long-term compliance. In this context, daily monitoring of the data teletransmitted means that we can be more responsive to problems of compliance during the first few days of use; the contribution of telemonitoring can be very positive in a context of poor compliance. In France, compulsory health insurance coverage of CPAP treatment is authorised for patients aged over 16 with clinical symptoms and an AHI ≥15 events per hour and \<30 events/h in patients with severe cardiovascular co-morbidity. These patients are often not very sleepy due to sympathetic hypertonia with a shorter sleep duration. They are at high risk of non-compliance. The IPIAM study specifically targets a population at cardiovascular risk and at high risk of non-compliance with CPAP treatment. The IPIAM study aims to involve patients in the success of their treatment via remote monitoring and to show that this approach makes it possible to improve the handling of alerts and to participate in the therapeutic support of the patient. Finally, this population also shares the risk of heart rhythm disorders. As part of a cross-disciplinary inter-pathology telemonitoring approach, it also makes sense to screen for cardiac rhythm disorders by wearing a connected watch.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-07-21; most recent amendment 2026-06-24.
Status change: Recruiting → Active, Not Recruiting 2026-06-24
Status change: Not Yet Recruiting → Recruiting 2023-10-20
Trial Details
NCT Number NCT05960175
Lead Sponsor Asten Sante
Collaborators: Slb Pharma, Nouvéal, Withings
Conditions OSA
Enrollment 556 participants
Start Date 2023-09-29
Primary Completion 2026-02-28 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-26