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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
CPAP treatment with telemedicine system
Standard care, including CPAP
Liberal Office
Boulogne-Billancourt, France
Clermont Tonerre military hospital
Brest, France
Liberal Office
Chambéry, France
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.
Time frame: 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.
Time frame: Home arterial Blood Pressure is assessed at week 16
CPAP compliance
the CPAP compliance is assessed in the two groups at week 16
Time frame: week 16
Sleepiness
Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
Time frame: 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.
Time frame: week 1
Quality of Life
Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
Time frame: week 16
Cardiovascular risk SCORE
The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
Time frame: Week 1
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Liberal Office
Grenoble, France
University Hospital
Grenoble, France
Liberal Office
Montigny-lès-Metz, France
Liberal Office
Nancy, France
Cornouaille Hospital
Quimper, France
Liberal Office
Saint Martin Les Boulogne, France
Montier Polyclinic
Saint-André-les-Vergers, France
...and 4 more locations
Sleepiness
Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
Time frame: 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.
Time frame: week 16
Quality of Life
Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
Time frame: week 1
Cardiovascular risk SCORE
The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
Time frame: Week 16