Sleep Apnea SyndromesPhase 4NCT00547937
Sleep Apnea and Oxidative Stress and Nitric Oxide
A Phase 4 study testing nasal continuous positive airway pressure (CPAP) therapy in people with Sleep Apnea Syndromes, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
Background: Previous studies present contradictory data concerning obstructive sleep apnea syndrome (OSAS), lipid oxidation and nitric oxide (NO) bioavailability. This study was aimed: (1) to compare the concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma of middle aged males with OSAS and no… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- nasal continuous positive airway pressure (CPAP) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- May 2001to Dec 2003
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- apnea-hypopnea index (AHI) ≥10 h-1
- excessive daytime sleepiness defined by an Epworth scale score ≥11 points
- no treatment for OSAS. Inclusion criteria for healthy control subjects were AHI <5 h-1 and Epworth sleepiness scale <10.
Who cannot join
- unwillingness or inability to participate in the study
- obstructive or restrictive lung disease as identified by pulmonary function testing
- use of cardioactive drugs
- cardiac rhythm disturbances, including sinus bradycardia and sinus tachycardia
- known arterial hypertension, or 24-hour mean blood pressure of 135 and/or 85 mm Hg or more
- left ventricular ejection fraction <50%, ischemic or valve heart disease, hypertrophic, restrictive or infiltrative cardiomyopathy, pericardial disease or stroke, by history, physical examination, ECG, chest radiography, conventional exercise stress testing, and echocardiography
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- diabetes mellitus, by history or 2 random blood glucose levels ≥126 mg/dl
- morbid obesity (body mass index >40 Kg/m2)
- daytime hypoxemia (PaO2 <70 mm Hg) or hypercapnia (PaCO2 >45 mm Hg)
- need to change medication
- hospital admission for 10 or more days
- average nightly CPAP usage less than 3.5 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nitrate and Oxidative Stress in Sleep Apnea Syndrome. Effect of Continuous Positive Airway Pressure
Background: Previous studies present contradictory data concerning obstructive sleep apnea syndrome (OSAS), lipid oxidation and nitric oxide (NO) bioavailability. This study was aimed: (1) to compare the concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma of middle aged males with OSAS and no other known comorbidity and carefully matched healthy controls of the same age and gender; and (2) to test the hypothesis that nasal continuous positive airway pressure (CPAP) therapy, might attenuate oxidative stress and nitrate deficiency.
Read the detailed description
We performed a single-center, prospective, randomized, double-blind, placebo-controlled and cross-over clinical study, in which patients received CPAP and sham therapy for two 12-week periods. Baseline measurements in healthy controls matched for age and gender were also obtained. At recruitment, 24-h blood pressure monitoring (ABPM), an echocardiogram (to rule out any cardiac dysfunction) and a sleep study was obtained in all participants . After fasting overnight, a venous blood sample (anti-coagulated with dipotassium EDTA, for 8-isoprostane and total nitrate and nitrite concentration (NOx) determinations) and a urine sample were collected in all of them between 08:00 and 10:00 hours. Within 30 minutes of blood collection, plasma was obtained by centrifugation at 3000 rpm for 15 min. All plasma samples were stored at -60°C until analysis. Patients with OSAS underwent a full-night CPAP titration study using an automated pressure setting device (Auto Set; ResMed, Sydney, Australia). Compliance with therapy was obtained from a built-in run-time counter. After 12 weeks, CPAP device was switched to the alternate mode of therapy and ABPM,, plasma and urine sampling were repeated in patients
- Conditions
- Sleep Apnea Syndromes
- Being tested
- nasal continuous positive airway pressure (CPAP) therapy
- Keywords
- Sleep Apnea, Oxidative Stress, Nitric oxide, Cardiovascular disease
- Medical subject headings
- Sleep Apnea Syndromes, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal continuous positive airway pressure (CPAP) therapyDevice
Nocturnal ventilation through a nasal mask to avoid sleep apneas
| Study group | Role | What they receive |
|---|---|---|
| Sham-CPAP | Sham comparator | The sham CPAP device consisted of a conventional CPAP device, in which the area of the exhalation port was amplified, thereby nearly cancelling nasal pressure; an orifice resistor was connected between the tubing and the CPAP unit that loads the blower with the same airflow resistance as in effective CPAP Receives: Device: nasal continuous positive airway pressure (CPAP) therapy |
| CPAP | Active comparator | Not described Receives: Device: nasal continuous positive airway pressure (CPAP) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startMay 2001
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Investigators
- Alberto Alonso, MD, Principal investigator, Sociedad Española de Neumología y Cirugía Torácica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547937
- Sponsor's protocol ID
- NO-OE-SAHS
- Status last verified
- Oct 2007
- First submitted
- 22 Oct 2007
- Last updated
- 9 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrate and Oxidative Stress in Sleep Apnea Syndrome. Effect of Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT00547937
- Acronym / sponsor ID
- NO-OE-SAHS
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep Apnea, Oxidative Stress, Nitric oxide, Cardiovascular disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- May 2001
- Study completion
- Dec 2003 (actual)
- First posted
- 23 Oct 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.
Background: Previous studies present contradictory data concerning obstructive sleep apnea syndrome (OSAS), lipid oxidation and nitric oxide (NO) bioavailability. This study was aimed: (1) to compare the concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma of middle aged males with OSAS and no other known comorbidity and carefully matched healthy controls of the same age and gender; and (2) to test the hypothesis that nasal continuous positive airway pressure (CPAP) therapy, might attenuate oxidative stress and nitrate deficiency.
Detailed description
We performed a single-center, prospective, randomized, double-blind, placebo-controlled and cross-over clinical study, in which patients received CPAP and sham therapy for two 12-week periods. Baseline measurements in healthy controls matched for age and gender were also obtained. At recruitment, 24-h blood pressure monitoring (ABPM), an echocardiogram (to rule out any cardiac dysfunction) and a sleep study was obtained in all participants . After fasting overnight, a venous blood sample (anti-coagulated with dipotassium EDTA, for 8-isoprostane and total nitrate and nitrite concentration (NOx) determinations) and a urine sample were collected in all of them between 08:00 and 10:00 hours. Within 30 minutes of blood collection, plasma was obtained by centrifugation at 3000 rpm for 15 min. All plasma samples were stored at -60°C until analysis. Patients with OSAS underwent a full-night CPAP titration study using an automated pressure setting device (Auto Set; ResMed, Sydney, Australia). Compliance with therapy was obtained from a built-in run-time counter. After 12 weeks, CPAP device was switched to the alternate mode of therapy and ABPM,, plasma and urine sampling were repeated in patients
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham-CPAP | Sham comparator | Device: nasal continuous positive airway pressure (CPAP) therapyThe sham CPAP device consisted of a conventional CPAP device, in which the area of the exhalation port was amplified, thereby nearly cancelling nasal pressure; an orifice resistor was connected between the tubing and the CPAP unit that loads the blower with the same airflow resistance as in effective CPAP |
| CPAP | Active comparator | Device: nasal continuous positive airway pressure (CPAP) therapy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- apnea-hypopnea index (AHI) ≥10 h-1
- excessive daytime sleepiness defined by an Epworth scale score ≥11 points
- no treatment for OSAS. Inclusion criteria for healthy control subjects were AHI <5 h-1 and Epworth sleepiness scale <10.
Key exclusion criteria (12 listed)
- unwillingness or inability to participate in the study
- obstructive or restrictive lung disease as identified by pulmonary function testing
- use of cardioactive drugs
- cardiac rhythm disturbances, including sinus bradycardia and sinus tachycardia
- known arterial hypertension, or 24-hour mean blood pressure of 135 and/or 85 mm Hg or more
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 continuous positive airway pressure (CPAP) therapyNocturnal ventilation through a nasal mask to avoid sleep apneas | Device | CPAP, Sham-CPAP |
Primary outcome
concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma
Time frame: 3 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 9 Nov 2007.
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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.
Alberto Alonso, MD principal investigator
Sociedad Española de Neumología y Cirugía Torácica
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 continuous positive airway pressure (CPAP) therapy in people with Sleep Apnea Syndromes, run by Sociedad Española de Neumología y Cirugía Torácica 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 12 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 9 Nov 2007. 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?
concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma (time frame: 3 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 9 Nov 2007.