Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients

Obstructive Sleep Apnea Clinical Trial

— EXAOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837018
• Other study ID #: 0520
• Secondary ID: DGS 2005/0312
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: March 4, 2013
• Start date: June 2005
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• physical exercise program
45 min, 3times a week

Locations

Country	Name	City	State
France	CHU, medecine du sport	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of maximal oxygen consumption : OSAS patient versus control subjects.		when the last patient realised the last visit	No
Secondary	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	No