Actively Recruiting
Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP for Obstructive Sleep Apnea with Cardiovascular Risk
Led by Asten Sante · Updated on 2025-08-11
556
Participants Needed
11
Research Sites
38 weeks
Total Duration
On this page
Sponsors
A
Asten Sante
Lead Sponsor
S
Slb Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults with newly diagnosed obstructive sleep apnea (OSA) who also have cardiovascular risk factors to evaluate two different telemonitoring methods for continuous positive airway pressure (CPAP) treatment. This study focuses on improving treatment adherence and managing alerts by involving patients directly, using connected devices for remote monitoring. The study targets a high-risk group often less sleepy but at increased risk of non-compliance and heart rhythm problems. Participants will all use the same CPAP ventilator (AirSense 11 Autoset, ResMed) and be randomly assigned to either standard telemonitoring by a home healthcare provider or a new method where patients manage alerts via a connected watch and mobile app during the first 4 months. After this period, all receive standard monitoring until one year of treatment. CPAP alerts are reviewed weekly by technicians, and patients have two pulmonology visits: one at inclusion and one after 4 months. Throughout the study, researchers will monitor CPAP adherence at 4 months and long-term adherence up to one year. They will assess quality of treatment by measuring leaks and apnea hypopnea index monthly for the first 4 months, track heart rate and respiratory events, and record medical consultations and hospitalizations related to OSA. Patient feedback and the number of home healthcare interventions will also be collected to evaluate the impact of telemonitoring approaches.
CONDITIONS
Brief 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 obstructive sleep apnea (central apnea index less than 5 events per hour) and low sleepiness (Epworth score less than 11 at inclusion)
- At least one cardiovascular risk factor (such as obesity, type I or II diabetes, hypertension, heart failure with preserved ejection fraction, valve disease, history of atrial fibrillation, ischemic heart disease, or stroke)
- Owns a smartphone and agrees to use connected devices during the study
- Signed informed consent form
- Affiliated to a health insurance system or is a beneficiary
You will not qualify if you...
- Already using a CPAP machine
- Has permanent atrial fibrillation
- Health condition not stable or requiring heavy treatment
- Has cognitive problems
- Participating in another intervention research in pulmonology
- Considered a vulnerable subject
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for inclusion
Duration - 4 months
Participants receive CPAP treatment and are monitored through telemonitoring. One group uses standard telemonitoring managed by the home healthcare provider, while the other group uses a new telemonitoring approach involving connected devices and patient involvement in alert management.
2 pulmonology consultations; weekly remote monitoring with possible home visits
Duration - Up to 8 months after initial treatment phase
Participants continue CPAP treatment with standard telemonitoring only, with ongoing observation of treatment adherence and health outcomes.
Standard telemonitoring without additional visits; 1 pulmonology consultation at 4 months
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
J
Johan Dupuis
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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