Sleep ApneaPhase 4OSCAMSANCT00487929
Oxidative Stress and Cardiovascular Morbidity in Sleep Apnea-Hypopnea Syndrome (SAHS)
A Phase 4 study testing nasal CPAP in people with Sleep Apnea and Cardiovascular Diseases, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The purpose of this study is to compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Cardiovascular Diseases
- What is being tested?
- nasal CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2007to Oct 2012
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sleep apnea-hypopnea syndrome (AHI > 5)
- Excessive sleepiness (ESS > 11)
- No previous CPAP treatment
Who cannot join
- Blood pressure > 180/120 mmHg.
- Secondary hypertension
- Professional driver
- COPD, asthma, bronchiectasis, lung cancer, restrictive lung disorder, chest wall disease
- Neuromuscular disease or thyroid function abnormalities
- Morbid obesity (BMI > 40 Kg/m2).
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- Respiratory infection in the 2 last months.
- Anemia (Hb < 10 g/dl) or polyglobulia (Hct > 55%).
- Diurnal hypercapnia (PaCO2 > 45 mmHg) or moderate hypoxemia (PaO2 < 70 mmHg).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of the Relationship Between the Oxidative Stress and the Development of Cardiovascular Complications in the Sleep Apnea-hypopnea Syndrome (SAHS). Effect of the Treatment With CPAP
The purpose of this study is to compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.
Read the detailed description
Aim: To compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.
Design: randomized, double blind, of parallel groups and controlled with placebo study.
Study subjects: 53 patients with SAHS (23 with cardiovascular complications and 30 without cardiovascular complications), 23 patients with cardiovascular diseases without SAHS and 23 control subjects.
Interventions: Three months of treatment with therapeutic CPAP or with sham CPAP (placebo).
Determinations: clinical (cardiovascular morbidity) and anthropometric data. Fat free corporal mass, echocardiography, spirometry, ambulatory monitoring of the arterial pressure, endothelial reactivity. Oxidative stress biomarkers (8-isoprostane, homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites) in plasma and condensed exhaled air.Peripheral sensitivity to hypoxia. Urinary excretion of catecholamines.
- Conditions
- Sleep Apnea, Cardiovascular Diseases
- Being tested
- nasal CPAP, Sham CPAP
- Keywords
- sleep apnea, morbidity, cardiovascular, cpap, oxidative stress
- Medical subject headings
- Sleep Apnea Syndromes, Cardiovascular Diseases, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal CPAPDevice
Nocturnal
Sham CPAPDevice
Nocturnal
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | Continuous positive airway pressure Receives: Device: nasal CPAP |
| Sham CPAP | Sham comparator | Sham nasal continuous positive airway pressure Receives: Device: Sham CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic 8-isoprostane concentration
Measured: three months
Secondary outcomes (1)
Plasmatic and condensed exhaled air concentrations of homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Investigators
- Francisco García-Rio, PhD, Study chair, Servicio de Neumología. Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487929
- Sponsor's protocol ID
- HULP051937
- Acronym
- OSCAMSA
- Status last verified
- Oct 2008
- First submitted
- 18 Jun 2007
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of the Relationship Between the Oxidative Stress and the Development of Cardiovascular Complications in the Sleep Apnea-hypopnea Syndrome (SAHS). Effect of the Treatment With CPAP
- ClinicalTrials.gov ID
- NCT00487929
- Acronym / sponsor ID
- OSCAMSA / HULP051937
- Conditions
- Sleep Apnea, Cardiovascular Diseases
- Keywords
- sleep apnea, morbidity, cardiovascular, cpap, oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Jun 2007 (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 purpose of this study is to compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.
Detailed description
Aim: To compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.
Design: randomized, double blind, of parallel groups and controlled with placebo study.
Study subjects: 53 patients with SAHS (23 with cardiovascular complications and 30 without cardiovascular complications), 23 patients with cardiovascular diseases without SAHS and 23 control subjects.
Interventions: Three months of treatment with therapeutic CPAP or with sham CPAP (placebo).
Determinations: clinical (cardiovascular morbidity) and anthropometric data. Fat free corporal mass, echocardiography, spirometry, ambulatory monitoring of the arterial pressure, endothelial reactivity. Oxidative stress biomarkers (8-isoprostane, homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites) in plasma and condensed exhaled air.Peripheral sensitivity to hypoxia. Urinary excretion of catecholamines.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: nasal CPAPContinuous positive airway pressure |
| Sham CPAP | Sham comparator | Device: Sham CPAPSham nasal continuous positive airway pressure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sleep apnea-hypopnea syndrome (AHI > 5)
- Excessive sleepiness (ESS > 11)
- No previous CPAP treatment
Key exclusion criteria (9 listed)
- Blood pressure > 180/120 mmHg.
- Secondary hypertension
- Professional driver
- COPD, asthma, bronchiectasis, lung cancer, restrictive lung disorder, chest wall disease
- Neuromuscular disease or thyroid function abnormalities
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 |
|---|---|---|
| nasal CPAPNocturnal | Device | CPAP |
| Sham CPAPNocturnal | Device | Sham CPAP |
Primary outcome
Plasmatic 8-isoprostane concentration
Time frame: three months
1 secondary outcome
Plasmatic and condensed exhaled air concentrations of homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites.
Time frame: three months
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 2 Apr 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.
Francisco García-Rio, PhD study chair
Servicio de Neumología. Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nasal CPAP in people with Sleep Apnea and Cardiovascular Diseases, run by Hospital Universitario La Paz at 1 site in Spain.
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 3 inclusion and 9 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 2 Apr 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasmatic 8-isoprostane concentration (time frame: three months). 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 2 Apr 2013.