NCT05960175 Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
| NCT ID | NCT05960175 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asten Sante |
| Condition | OSA |
| Study Type | INTERVENTIONAL |
| Enrollment | 556 participants |
| Start Date | 2023-09-29 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 556 participants in total. It began in 2023-09-29 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Arnaud Prigent, Dr
PRINCIPAL INVESTIGATOR
Polyclinique Saint-Laurent
Frequently Asked Questions
Who can join the NCT05960175 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying OSA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05960175 currently recruiting?
Yes, NCT05960175 is actively recruiting participants. Contact the research team at al.serandour@slbpharma.com for enrollment information.
Where is the NCT05960175 trial being conducted?
This trial is being conducted at La Roche-sur-Yon, France, Paris, France, Angers, France, Dijon, France and 7 additional locations.
Who is sponsoring the NCT05960175 clinical trial?
NCT05960175 is sponsored by Asten Sante. The principal investigator is Arnaud Prigent, Dr at Polyclinique Saint-Laurent. The trial plans to enroll 556 participants.