Obstructive Sleep Apnea SyndromeSOREVASNCT00646971
Oxidative Stress and Endothelial Dysfunction in Obstructive Sleep Apnea
A study testing CPAP device in people with Obstructive Sleep Apnea Syndrome and Endothelial Dysfunction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients with sleep apnea syndrome have repeated apneic events that induce periodic hypoxia-reoxygenation, drawing away an overproduction of oxidants. This exaggerated generation of oxidants is associated with a dysfunction of the vascular endothelium that evolves, in its turn, towards cardiovascular diseases such as… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Endothelial Dysfunction, Oxidative Stress
- What is being tested?
- CPAP device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Apr 2010
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No smoking
- 30-70 years old subjects
- being referred for daytime hyper- somnolence and snoring
- apnea hypopnea index >=30/hour and desaturation index>=30/hour
Who cannot join
- Chronic lung diseases.
- Exposure to occupational contaminants.
- Active smoking within last 2 years.
- Alcoholism.
- Chronic systemic disease other than OSAS.
- Treatment with vasoactive drugs or antioxidants
- Respiratory infection or vaccination during the 6 weeks preceding the PSG1.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Clamart, 92141
About this study
Official title: Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.
Patients with sleep apnea syndrome have repeated apneic events that induce periodic hypoxia-reoxygenation, drawing away an overproduction of oxidants. This exaggerated generation of oxidants is associated with a dysfunction of the vascular endothelium that evolves, in its turn, towards cardiovascular diseases such as systemic hypertension, stroke, and myocardial infarction. The major aim of our study is to examine the effect of CPAP treatment on biochemical (markers of oxidative stress) and functional (endothelium-dependent vascular relaxation reactivity) abnormalities at 1 and 4 weeks of treatment.
Read the detailed description
Subjects will undergo overnight polysomnography in the sleep laboratory (PSG1, D0), which will be immediately preceded and followed by measurements of oxidative stress in exhaled gas and vascular relaxation. Patients included in the OSAS group will be randomly assigned to treatment by either CPAP or Placebo (sham CPAP) for 4 weeks. Measurements of oxidative stress in exhaled gas and vascular reactivity will be repeated immediately before and after PSG2 and PSG3 at D7 and D30, respectively.
- Conditions
- Obstructive Sleep Apnea Syndrome, Endothelial Dysfunction, Oxidative Stress, Intermittent Hypoxia, Cardiovascular Risk
- Being tested
- CPAP device, Placebo device
- Keywords
- Isoprostane, Alkane, Exhaled condensate, Peripheral arterial tonometry, Polysomnography, Obstructive Sleep Apnea, Hypoxia
- Medical subject headings
- Sleep Apnea, Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP deviceDevice
Also called CPAP
for 4 weeks
Placebo deviceDevice
Also called Placebo
for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CPAP Receives: Device: CPAP device |
| 2 | Sham comparator | sham CPAP Receives: Device: Placebo device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities
Measured: 1 and 4 weeks of treatment
Secondary outcomes (4)
To compare between patients with severe OSAS and controls, the degree of the production of markers of oxidative stress non-invasively measured in both the exhaled gas and urine samples
Measured: before and after a nocturnal polysomnography
To compare between patients and controls, the endothelium-dependent vascular relaxation
Measured: before and after nocturnal polysomnography
To analyze the relationship between these biochemical and functional abnormalities and the standard criteria of severity of OSAS.
Measured: before and after nocturnal polysomnography
To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities
Measured: 1 and 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Insuffisent recrutment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Pierre ESCOURROU, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris Hôpital Antoine BéclèreGabriel ROISMAN, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646971
- Sponsor's protocol ID
- P041012
- Acronym
- SOREVAS
- Status last verified
- May 2010
- First submitted
- 17 Mar 2008
- Last updated
- 12 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Markers of Oxidative Stress and Endothelium-dependent Vascular Relaxation in Obstructive Sleep Apnea. Effect of Continuous Positive Airway Pressure Therapy.
- ClinicalTrials.gov ID
- NCT00646971
- Acronym / sponsor ID
- SOREVAS / P041012
- Conditions
- Obstructive Sleep Apnea Syndrome, Endothelial Dysfunction, Oxidative Stress, Intermittent Hypoxia, Cardiovascular Risk
- Keywords
- Isoprostane, Alkane, Exhaled condensate, Peripheral arterial tonometry, Polysomnography, Obstructive Sleep Apnea, Hypoxia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insuffisent recrutment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 31 Mar 2008 (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.
Patients with sleep apnea syndrome have repeated apneic events that induce periodic hypoxia-reoxygenation, drawing away an overproduction of oxidants. This exaggerated generation of oxidants is associated with a dysfunction of the vascular endothelium that evolves, in its turn, towards cardiovascular diseases such as systemic hypertension, stroke, and myocardial infarction. The major aim of our study is to examine the effect of CPAP treatment on biochemical (markers of oxidative stress) and functional (endothelium-dependent vascular relaxation reactivity) abnormalities at 1 and 4 weeks of treatment.
Detailed description
Subjects will undergo overnight polysomnography in the sleep laboratory (PSG1, D0), which will be immediately preceded and followed by measurements of oxidative stress in exhaled gas and vascular relaxation. Patients included in the OSAS group will be randomly assigned to treatment by either CPAP or Placebo (sham CPAP) for 4 weeks. Measurements of oxidative stress in exhaled gas and vascular reactivity will be repeated immediately before and after PSG2 and PSG3 at D7 and D30, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CPAP deviceCPAP |
| 2 | Sham comparator | Device: Placebo devicesham CPAP |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No smoking
- 30-70 years old subjects
- being referred for daytime hyper- somnolence and snoring
- apnea hypopnea index >=30/hour and desaturation index>=30/hour
Key exclusion criteria (7 listed)
- Chronic lung diseases.
- Exposure to occupational contaminants.
- Active smoking within last 2 years.
- Alcoholism.
- Chronic systemic disease other than OSAS.
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 |
|---|---|---|
| CPAP deviceAlso: CPAPfor 4 weeks | Device | 1 |
| Placebo deviceAlso: Placebofor 4 weeks | Device | 2 |
Primary outcome
To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities
Time frame: 1 and 4 weeks of treatment
4 secondary outcomes
To compare between patients with severe OSAS and controls, the degree of the production of markers of oxidative stress non-invasively measured in both the exhaled gas and urine samples
Time frame: before and after a nocturnal polysomnography
To compare between patients and controls, the endothelium-dependent vascular relaxation
Time frame: before and after nocturnal polysomnography
To analyze the relationship between these biochemical and functional abnormalities and the standard criteria of severity of OSAS.
Time frame: before and after nocturnal polysomnography
To examine the effect of CPAP treatment on functional (endothelium-dependent vascular relaxation reactivity) abnormalities
Time frame: 1 and 4 weeks of treatment
Results and safety
The study was stopped early (reason given: Insuffisent recrutment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2010.
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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.
Pierre ESCOURROU, MD, PhD study director
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Gabriel ROISMAN, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris, Hôpital Antoine Béclère
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP device in people with Obstructive Sleep Apnea Syndrome and Endothelial Dysfunction, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Jul 2010. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Insuffisent recrutment). Results are not available in the source record.
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?
To examine the effect of CPAP treatment on biochemical (markers of oxidative stress) abnormalities (time frame: 1 and 4 weeks of treatment). 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 12 Jul 2010.