Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to 4% of the general population. The patients with OSAS frequently complain of intolerance to exercise muscle fatigue and a significant even if they have not been fully characterized in the literature. The anomalies in the exercise of patients with OSAS could be due to metabolic changes (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity). Our goal is both to determine whether these anomalies exist in patients with OSAS not obese, consider their relationship with the alteration of exercise capacity, and their reversibility in conventional PPC or by using the effects of physical activity regular.In this study Objectives: To establish whether the metabolic and vascular abnormalities associated with OSAS are associated with decreased parameters of physical fitness in relation to witnesses matched for age, sex and body mass index. Determine the effects of a re-training exercise on these parameters compared to the reference treatment, continuous positive pressure. Main objective: To compare the exercise capacity of OSAS patients compared with that of witnesses matched for age, sex and body mass index. Secondary objectives: To compare the effect of conventional treatment by continuous positive pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic modality most original, physical activity. Methodology: Test physiopathological parallel group, controlled, randomized.

Detailed Description
-----------------
Study type : Physiopathology trial Study design : Prospective randomized controled trial Expected Total Enrollment : 45 patients + 15 control subjects Tested treatment : Physical exercise program (45 minutes, 3 times a week) Reference treatment : continuous positive airway pressure Treatment duration : 12 weeks (3 months) Total study duration : 2 years

Official Title
-----------------
Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: physical exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages Eligible for Study : 18 Years and above Genders Eligible for Study: Both Non obese : body mass index (BMI < 30 kg/m2) Sedentary subjects : less physical activity than 30 minutes 3 time a week and VOORIPS physical activity level questionnaire score < 9. Obstructive sleep apnea syndrome (OSAS) patients : Recently diagnosed (< 3 months) AHI > 30 / hour (polysomnographic monitoring measurement) Exclusion Criteria: Excessive daytime sleepiness (Epworth score > 12) Cardiovascular pathology (except controlled hypertension) Pathology interacting with physical activity Diabetes (known or treated) Other participation to a clinical trial at the same

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical exercise program<br>45 min, 3 times a week | Other: physical exercise program<br>* 45 min, 3times a week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of maximal oxygen consumption : OSAS patient versus control subjects. |  | when the last patient realised the last visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare physical exercise program to continuous positive airway pressure after 12 weeks of treatment in OSAS patients. |  | when the last patient realised the last visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSAS, exercise, metabolic, cardio-vascular