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NCT Number: NCT00837018

Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Behavior Dyssomnias Motor Activity Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU, medecine du sport

Grenoble, 38000, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise program

Other

45 min, 3times a week

Primary outcomes

  1. Comparison of maximal oxygen consumption : OSAS patient versus control subjects.

    Time frame: when the last patient realised the last visit

Secondary outcomes

  1. To compare physical exercise program to continuous positive airway pressure after 12 weeks of treatment in OSAS patients.

    Time frame: when the last patient realised the last visit

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • AGIR à Dom

Registry information

Official study title

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

Acronym: EXAOS

Important dates

Study start
2005
Primary completion
2010
Study completion
2012
First posted
Feb 4, 2009
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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