Clinical trial NCT05960175: Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
Official title: Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: OSA
Keywords: OSA
Cheyne-Stokes respiration (CSR)
Continuous positive airway pressure (CPAP)
Telemedicine
Lead sponsor: Asten Sante
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
name: Nouvéal
name: Withings
First posted: 2023-07-25
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: CPAP treatment adherence
timeFrame: Month 4
Secondary outcomes:
measure: Quality of CPAP treatment assessed by leaks
timeFrame: Month 1, Month 2, Month 3, Month 4
measure: Quality of CPAP treatment assessed by apnea hypopnea index
timeFrame: Month 1, Month 2, Month 3, Month 4
measure: long term CPAP treatment adherence
timeFrame: Month 6, Year 1
measure: Number of nights with Cheynes Stoke Respirations (CSR)
timeFrame: over the first 4 months
measure: Nocturnal heart rate
timeFrame: over the first 4 months
measure: Number of alerts
timeFrame: over the first 4 months
measure: Number of medical events (pneumology and cardiology consultations, hospitalizations) related to OSA
timeFrame: Month 4
measure: SEMSA15 questionnaire
timeFrame: CPAP initiation (baseline), month 4, month 6, year 1
measure: F-SUS questionnaire
timeFrame: Month 4
measure: Number of home healthcare provider interventions
timeFrame: over the first 4 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers - Service de pneumologie
city: Dijon
country: France
facility: CHU Dijon-Bourgogne
city: Le Chesnay
country: France
facility: CH Versailles
city: Le Mans
country: France
facility: CH Le Mans
city: Nancy
country: France
facility: CHU Nancy
city: Paris
country: France
facility: AP-HP Pitié Salpêtrière
city: Paris
country: France
facility: AP-HP Bichat Claude Bernard
city: Rennes
country: France
facility: Polyclinique Saint-Laurent - Groupe médical de pneumologie
city: Rouen
country: France
facility: CHU Rouen - Charles Nicolle
Study officials:
affiliation: Polyclinique Saint-Laurent
name: Arnaud Prigent, Dr
role: PRINCIPAL_INVESTIGATOR
References: