Active — Not RecruitingNot Applicable

Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP

France556 participantsStarted 2023-09-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

CPAP treatment adherence

Timeframe: Month 4

Trial details

NCT IDNCT05960175

SponsorAsten Sante

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-28

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