RecruitingNot ApplicableNCT05960175

Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP


Sponsor

Asten Sante

Enrollment

556 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

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Interventions

DEVICENew telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application

The home healthcare provider will monitor the treatment remotely and make home visits, as in the control group. However, in the case of technical alerts concerning CPAP treatment (problems with observance, leaks, residual apneas), the provider will send the patient a notification via the mobile application in order to provide advice/instructions so that the patient can resolve the alert independently. The provider will monitor the resolution of alerts remotely and may contact the patient by telephone or come to your home if necessary. If the connected watch detects an abnormal heart rhythm at night, the patient receives a notification and can undergo an electrocardiogram.


Locations(11)

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

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NCT05960175


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