Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
NCT ID: NCT05960175
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
556 participants
INTERVENTIONAL
2023-09-29
2026-10-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard CPAP telemonitoring
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).
No interventions assigned to this group
New CPAP telemonitoring approach
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Slb Pharma
OTHER
Nouvéal
UNKNOWN
Withings
INDUSTRY
Asten Sante
INDUSTRY
Responsible Party
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Principal Investigators
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Arnaud Prigent, Dr
Role: PRINCIPAL_INVESTIGATOR
Polyclinique Saint-Laurent
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Acya Bizieux, Dr
Role: primary
Sven GÜNTHER, Dr
Role: primary
Frédérique Gagnadoux, Pr
Role: primary
Pauline Sabot, Dr
Role: primary
Alice De Sanctis, Dr
Role: primary
François Goupil, Dr
Role: primary
Ari Chaouat, Pr
Role: primary
Maxime Patout, Dr
Role: primary
Marie-Pia D'Ortho, Pr
Role: primary
Arnaud Prigent, Dr
Role: primary
Marie-Anne Melone, Dr
Role: primary
Other Identifiers
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IPIAM
Identifier Type: -
Identifier Source: org_study_id
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