Informations générales (source: ClinicalTrials.gov)
Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
Interventional
N/A
Asten Sante (Voir sur ClinicalTrials)
septembre 2023
février 2027
28 juin 2026
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | Contact (sur clinicalTrials) | ||||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Départemental Vendée - 85925 - La Roche-sur-Yon - France - France | Contact (sur clinicalTrials) | ||||
| CHU Dijon-Bourgogne - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU Rouen - Charles Nicolle - 76000 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP Hôpital Européen Georges - 75015 - Paris - France - France | Contact (sur clinicalTrials) | ||||
| AP-HP Pitié Salpêtrière - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
| CH Le Mans - 72037 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| CHU Angers - Service de pneumologie - 49100 - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU Nancy - 54511 - Nancy - France | Contact (sur clinicalTrials) | ||||
| Polyclinique Saint-Laurent - Groupe médical de pneumologie - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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