Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study
- Conditions
- Sleep Apnea SyndromeLow Cardiovascular Risk
- Interventions
- Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
- Registration Number
- NCT01796769
- Lead Sponsor
- Fédération Française de Pneumologie
- Brief Summary
Targeted population:
Sleep apnea patients at low cardiovascular risk newly treated by CPAP
Hypothesis:
Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP care.
Main goal:
To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.
- Detailed Description
Study procedures:
The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of oximetry, CPAP compliance, side effects and residual events.
Secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events.
An interim analysis will be performed when 200 patients will be included.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 936
- Age between 18 to 78 years
- Men and women
- AHI > 30 / hour
- Patient with low cardiovascular score (<5% defined by European SCORE)
- Patient affiliated to the national health insurance
- Willingness to use a telemonitoring system
- Known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
- Central sleep apnea syndrome
- Previous CPAP treatment with respiratory support for sleep respiratory trouble
- Cardiac failure
- Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg)
- Terminal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Continuous Positive Airway Pressure (CPAP) in sleep apnea patients - Telemedicine Continuous Positive Airway Pressure (CPAP) in sleep apnea patients -
- Primary Outcome Measures
Name Time Method Change from baseline CPAP compliance at 6 months day 0 and month 6 CPAP compliance evolution by comparing baseline and 6 months measurements. CPAP compliance is assessed at month 6 in the two groups.
- Secondary Outcome Measures
Name Time Method Subjective Sleepiness inclusion and month 6 Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
Quality of Life inclusion and month 6 Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups
Cost analysis month 6 Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use)
Fatigue inclusion and month 6 Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
Health status inclusion and month 6 Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups
Trial Locations
- Locations (12)
Hospital Nord Ouest
🇫🇷Villefranche Sur Saone, France
Dieulefit Santé Clinic
🇫🇷Dieulefit, France
Tessier Clinic
🇫🇷Valenciennes, France
Saint Vincent Clinic
🇫🇷Epernay, France
La Louvière Clinic
🇫🇷Lille, France
University Hospital
🇫🇷Rouen, France
University Hospital Calmette
🇫🇷Lille, France
General Hospital
🇫🇷St Avold, France
Ambroise Paré Hospital
🇫🇷Marseille, France
Les Rieux Clinic
🇫🇷Nyons, France
Hospital Bichat Claude Bernard
🇫🇷Paris, France
Respiratory physician in private practice
🇫🇷Valence, France