Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk

Study Overview
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Brief Summary
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The aim of this study is to determine the usefulness of a telemedicine system for the follow-up of OSA patients with a high cardiovascular risk. Our hypothesis is that the telemedicine system will enhance compliance and thus reduce self-measured blood pressure.

Detailed Description
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The obstructive sleep apnea syndrome (OSAS) corresponds to repeated epochs of complete or incomplete pharynx collapses occurring during sleep. The Continuous Positive Airway Pressure is the gold standard treatment for OSAS. It consists of air insufflation in upper airways with a pressure of about 5 to 15 cm of water with a facial or nasal mask. CPAP treatment reduces cardiovascular morbi-mortality. OSAS is associated with cardiovascular mortality. A dose response effect exists between severity and arterial blood pressure. A recent meta-analysis has shown in unselected OSAS patients with or without hypertension, treated or non-treated for hypertension, CPAP reduces 24 h ambulatory blood pressure of approximately 2 mmHg. This decrease corresponds to a significant reduction in cardiovascular risk. The aim of the present study is to include OSAS patients with a high cardiovascular risk and to measure the effect of CPAP on home measurements of arterial blood pressure. This controlled randomized trial will compare the effect CPAP on arterial blood pressure in a group with a telemedicine system versus a group with standard home care CPAP treatment. An interim analysis will be carried out when 100 patients have been included in the study.

Official Title
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Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk

Conditions
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Sleep Apnea, Obstructive, Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: Telemedicine
* Device: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 85 years old men and women stable patient BMI<40kg/m² OSA patients diagnosed with polysomnography or polygraphy SCORE>5% and/or cardiovascular disease pas history : transient ischemic attack, stroke, cerebral haemorrhagy myocardial infraction, angor, coronary revascularization, arteriopathy, aortic aneurism Exclusion Criteria: central sleep apnea syndrome SCORE<5% cardiac failure past history of hypercapnic chronic respiratory failure past history of severe or intercurrent pathology which can not allow the patient follow-up Incapacitated patients in accordance with article L 1121-6 of the public health code patients taking part in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedecine<br>CPAP treatment with telemedicine system | Device: Telemedicine<br>* CPAP treatment with telemedicine system<br>|
| Active Comparator: Standard Care<br>Standard care, including CPAP | Device: Standard care<br>* Standard care, including CPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home Arterial Blood Pressure | the primary outcome is assessed at weeks 1 and 16 for the both groups, moreover home arterial blood pressure is assessed each day, 2 times : morning and afternoon in the telemedicine group. | Home arterial Blood Pressure is assessed at week 1 | 
| Home Arterial Blood Pressure | the primary outcome is assessed at weeks 1 and 16 for the both groups, moreover home arterial blood pressure is assessed each day, 2 times : morning and afternoon in the telemedicine group. | Home arterial Blood Pressure is assessed at week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP compliance | the CPAP compliance is assessed in the two groups at week 16 | week 16 | 
| Sleepiness | Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups | weeks 1 and 16 | 
| Physical Activity | Daily Physical Activity is assessed with an accelerometer (Sensewear Armband, Bodymedia) at weeks 1 and 16 in the two groups. Daily expenditure, steps number, daily METs are assessed. | week 1 | 
| Quality of Life | Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups. | week 16 | 
| Cardiovascular risk SCORE | The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups. | Week 1 | 
| Sleepiness | Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups | week 16 | 
| Physical Activity | Daily Physical Activity is assessed with an accelerometer (Sensewear Armband, Bodymedia) at weeks 1 and 16 in the two groups. Daily expenditure, steps number, daily METs are assessed. | week 16 | 
| Quality of Life | Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups. | week 1 | 
| Cardiovascular risk SCORE | The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups. | Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea Syndrome, SCORE, Telemedicine, Arterial blood pressure, Daily physical activity