Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study

Study Overview
=================
Brief Summary
-----------------
Targeted population: Sleep apnea patients at high cardiovascular risk newly treated by CPAP Hypothesis: Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care. Main goal: To compare 6-months blood pressure reduction when Sleep Apnea patients at high 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 home self-measured blood pressure, oximetry, physical activity recorded by actigraphy, 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 300 patients will be included.

Official Title
-----------------
Blood Pressure Reduction Induced by Continuous Positive Airway Pressure (CPAP) in Sleep Apnea Patients at High Cardiovascular Risk : A Randomized Controlled Trial Comparing Usual CPAP Care Versus a Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform

Conditions
-----------------
Sleep Apnea Syndromes, High Cardiovascular Risk

Intervention / Treatment
-----------------
* Device: CPAP treatment
* Device: CPAP treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 to 78 years Men and women AHI > 30 / hour Patient with high cardiovascular score (>5% defined by European SCORE) or known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease) Patient affiliated to the National health insurance Willingness to use a telemonitoring system Exclusion Criteria: Central sleep apnea syndrome Previous CPAP treatment with respiratory support for sleep respiratory trouble Cardiac failure with left ventricular ejection fraction lesser than 40% Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg) Terminal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional<br> | Device: CPAP treatment<br>* Usual CPAP treatment<br>|
| Active Comparator: Telemedicine<br> | Device: CPAP treatment<br>* CPAP treatment with telemedicine system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure evolution by comparing baseline and 6 months measurements | Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days) | day 0 and month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective CPAP compliance at 6 months | CPAP compliance assessed after 6 months in the two groups | day 0 and month 6 | 
| Diastolic blood pressure evolution by comparing baseline and 6 months | Diastolic blood pressure is assessed at day 0 and month 6 in the two groups | day 0 and month 6 | 
| Subjective Sleepiness | Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups | inclusion and month 6 | 
| Fatigue | Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups | inclusion and month 6 | 
| Quality of Life | Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups | inclusion and month 6 | 
| Health status | Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups | inclusion and month 6 | 
| Physical activity | Physical activity is assessed with actimetry at inclusion and month 6 in the two groups | inclusion and month 6 | 
| Cost analysis | Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use) | month 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea Syndrome, Apnea, Sleep Apnea, Telemedicine, CPAP compliance