EICHORCondition: OSA · Sponsor: Asten Sante
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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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| CH Départemental Vendée | La Roche-sur-Yon, France, France | — |
| AP-HP Hôpital Européen Georges | Paris, France, France | — |
| CHU Angers - Service de pneumologie | Angers, France | — |
| CHU Dijon-Bourgogne | Dijon, France | — |
| CH Versailles | Le Chesnay, France | — |
| CH Le Mans | Le Mans, France | — |
| CHU Nancy | Nancy, France | — |
| AP-HP Pitié Salpêtrière | Paris, France | — |
| AP-HP Bichat Claude Bernard | Paris, France | — |
| Polyclinique Saint-Laurent - Groupe médical de pneumologie | Rennes, France | — |
| CHU Rouen - Charles Nicolle | Rouen, France | — |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT05960175