Actively Recruiting
Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
Led by Asten Sante · Updated on 2025-08-11
556
Participants Needed
11
Research Sites
161 weeks
Total Duration
On this page
Sponsors
A
Asten Sante
Lead Sponsor
S
Slb Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult with newly diagnosed OSA (central apnea index <5 events/hour) and low sleepiness (Epworth score <11 at inclusion)
- At least 1 cardiovascular risk factor (obesity, type I or II diabetes, permanent hypertension, heart failure with preserved ejection fraction, valve disease, history of atrial fibrillation, ischaemic heart disease, or stroke)
- Owns a smartphone and agrees to use connected devices during the study
- Signed informed consent form
- Affiliated with a health insurance system or beneficiary
You will not qualify if you...
- Already fitted with a CPAP machine
- Permanent atrial fibrillation
- Unstable health or requires heavy treatment
- Cognitive problems
- Participating in another intervention research in pulmonology
- Considered a vulnerable subject
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
CH Départemental Vendée
La Roche-sur-Yon, France, France, 85925
Actively Recruiting
2
AP-HP Hôpital Européen Georges
Paris, France, France, 75015
Actively Recruiting
3
CHU Angers - Service de pneumologie
Angers, France, 49100
Actively Recruiting
4
CHU Dijon-Bourgogne
Dijon, France, 21000
Actively Recruiting
5
CH Versailles
Le Chesnay, France, 78150
Actively Recruiting
6
CH Le Mans
Le Mans, France, 72037
Actively Recruiting
7
CHU Nancy
Nancy, France, 54511
Actively Recruiting
8
AP-HP Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
9
AP-HP Bichat Claude Bernard
Paris, France, 75018
Actively Recruiting
10
Polyclinique Saint-Laurent - Groupe médical de pneumologie
Rennes, France, 35000
Actively Recruiting
11
CHU Rouen - Charles Nicolle
Rouen, France, 76000
Actively Recruiting
Research Team
A
Anne-Laure Sérandour
CONTACT
J
Johan Dupuis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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