Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP

Asten Santé

Status: Enrolling

Conditions: OSA

Treatments: Device: New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05960175

IPIAM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 556 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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556 participants in 2 patient groups

Standard CPAP telemonitoring

No Intervention group

Description:

Patients are treated with CPAP and the home healthcare provider carries out monitoring in line with current practice (telemonitoring of treatment and regular home visits).

New CPAP telemonitoring approach

Experimental group

Description:

Patients are treated with CPAP and the home healthcare provider is offering a new approach to remote monitoring in which patients are involved in managing their CPAP treatment using two connected devices (the Scanwatch connected watch + the mobile application Asten\&masanté) in the first 4 months of treatment.

Treatment:

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