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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
556
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.
CH Départemental Vendée
La Roche-sur-Yon, France, France
RECRUITINGAP-HP Hôpital Européen Georges
Paris, France, France
RECRUITINGCHU Angers - Service de pneumologie
Angers, France
RECRUITINGCHU Dijon-Bourgogne
Dijon, France
RECRUITINGCH Versailles
Le Chesnay, France
RECRUITINGCH Le Mans
Le Mans, France
RECRUITINGCHU Nancy
Nancy, France
RECRUITINGAP-HP Pitié Salpêtrière
Paris, France
RECRUITINGAP-HP Bichat Claude Bernard
Paris, France
RECRUITINGPolyclinique Saint-Laurent - Groupe médical de pneumologie
Rennes, France
RECRUITING...and 1 more locations
CPAP treatment adherence
Measurement of the average daily duration of use of the CPAP (expressed in hours) over the last 30 nights, 4 months after initiation of treatment. The duration of use will be compared between both groups.
Time frame: Month 4
Quality of CPAP treatment assessed by leaks
Measurement of the average leaks (expressed in liter per minute) per month using the daily data teletransmitted by CPAP ventilator throughout the follow-up period.
Time frame: Month 1, Month 2, Month 3, Month 4
Quality of CPAP treatment assessed by apnea hypopnea index
Measurement of the average residual apnea hypopnea index (expressed in number of event per hour) per month using the daily data teletransmitted by CPAP ventilator throughout the follow-up period.
Time frame: Month 1, Month 2, Month 3, Month 4
long term CPAP treatment adherence
Measurement of the average daily duration of use of the CPAP (expressed in hours) over the last 30 nights, 6 months and 1 year after initiation of treatment.
Time frame: Month 6, Year 1
Number of nights with Cheynes Stoke Respirations (CSR)
Average number of nights with CSR per patient per 30-day period during the first 4 months of treatment.
Time frame: over the first 4 months
Nocturnal heart rate
Night-time heart rate teletransmitted daily by the connected watch during the first 4 months, only in the experimental group.
Time frame: over the first 4 months
Number of alerts
Average number of technical and medical alerts (related to adherence, leaks, apnea, CSR, increase in heart rate, atrial fibrillation) per patient per 30-day period during the first 4 months of treatment.
Time frame: over the first 4 months
Number of medical events (pneumology and cardiology consultations, hospitalizations) related to OSA
Average number of medical events (pneumology and cardiology consultations, hospitalizations) related to OSA per patient
Time frame: Month 4
F-SUS questionnaire
The French System Usability Scale (SUS) is a questionnaire evaluating the patient satisfaction on usability of interactive systems. The questionnaire comprises 10 questions and the score of user satisfaction varies from 0 to 100 (0 lowest score; 100 highest score).
Time frame: Month 4
Number of home healthcare provider interventions
Average number of home healthcare provider interventions (phone call, home visit, remote assistance) per patient.
Time frame: over the first 4 months
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