NCT05960175

Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 556 (estimated)
• Sponsor: Asten Sante · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

IPIAM is a prospective randomized controled study with two arms. Two approaches to telemonitoring will be compared: the standard telemonitoring carried out by the home healthcare provider (standard of care) will be compared with a new approach in which the patient is involved in managing his treatment by collecting vitals and notifying alerts via two connected devices (a connected watch and a mobile application). The study will comprise 2 phases : 1. an initial interventional, comparative, randomised phase corresponding to the first 4 months of CPAP treatment, 2. an observational period with standard telemonitoring, lasting until the 12th month of treatment. In this study, all patients will be treated with the same continuous positive airway pressure ventilator (AirSense 11 Autoset, ResMed). CPAP alerts will be checked by the home healthcare provider's technicians every week and then managed differently depending on the randomisation group. Each patient will be seen twice in pulmonology consultations, once for the inclusion visit and once 4 months after CPAP initation.

Conditions

• OSA

Interventions

Type	Name	Description
DEVICE	New 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.

Timeline

• Start date: 2023-09-29
• Primary completion: 2026-01-31
• Completion: 2026-10-30
• First posted: 2023-07-25
• Last updated: 2025-08-11

Locations

11 sites across 1 country: France