Obstructive Sleep ApneaEXAOSNCT00837018
Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients
A study testing physical exercise program in people with Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- physical exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.
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).
Read more
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.
Read the 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
- Conditions
- Obstructive Sleep Apnea
- Being tested
- physical exercise program
- Keywords
- OSAS, exercise, metabolic, cardio-vascular
- Medical subject headings
- Sleep Apnea, Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exercise programOther
45 min, 3times a week
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise program | Experimental | 45 min, 3 times a week Receives: Other: physical exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of maximal oxygen consumption : OSAS patient versus control subjects.
Measured: 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.
Measured: when the last patient realised the last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startJun 2005
- Primary completionMay 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- AGIR à Dom
- Responsible party
- Sponsor
- Investigators
- Bernard Wuyam, doctor, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837018
- Sponsor's protocol ID
- 0520
- Other IDs
- DGS 2005/0312
- Acronym
- EXAOS
- Status last verified
- Mar 2013
- First submitted
- 3 Feb 2009
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.
- ClinicalTrials.gov ID
- NCT00837018
- Acronym / sponsor ID
- EXAOS / 0520
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSAS, exercise, metabolic, cardio-vascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- AGIR à Dom
- Study start
- Jun 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical exercise program | Experimental | Other: physical exercise program45 min, 3 times a week |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical exercise program45 min, 3times a week | Other | Physical exercise program |
Primary outcome
Comparison of maximal oxygen consumption : OSAS patient versus control subjects.
Time frame: when the last patient realised the last visit
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Wuyam, doctor principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise program in people with Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of maximal oxygen consumption : OSAS patient versus control subjects. (time frame: when the last patient realised the last visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013.