Sleep ApneaNCT00701441
The Role of Oxidative Stress in the Cardiovascular Consequences of Sleep Apnea
An observational study of Sleep Apnea, run by Rami Khayat at 1 site in United States.
Trial summary
Obstructive Sleep Apnea (OSA) is the most common sleep disorder affecting up to 9-24 percent of middle aged adults, and is becoming increasingly implicated in the pathogenesis of hypertension, and other cardiovascular disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People screened for sleep apnea with a completed sleep study who do not have hypertension or coronary artery disease.
Who may be able to join
- Completed sleep study - Older than 18
Who cannot join
- Hypertension
- Diabetes
- coronary disease
- Peripheral vascular disease
- High cholesterol
- Smoking
- Pregnancy
- Use of erectile dysfunction medications or supplements
Trial locations and contacts
1 site in 1 country.
About this study
Obstructive Sleep Apnea (OSA) is the most common sleep disorder affecting up to 9-24 percent of middle aged adults, and is becoming increasingly implicated in the pathogenesis of hypertension, and other cardiovascular disorders. Up to half of patients with OSA have hypertension, and their risk of developing hypertension increases with the increasing severity of Sleep Apnea. Patients with OSA and no hypertension have endothelial dysfunction, which is believed to be the precursor for most cardiovascular disorders.
The upper airway collapse and obstruction that occur in OSA result in a pattern of intermittent hypoxia, that has been shown to be the cause of the hypertension, and endothelial dysfunction found in patients with OSA. Intermittent hypoxia results in oxidative stress, which in turn is linked to the pathogenesis of hypertension and endothelial dysfunction.
This protocol evaluates the role of the oxidative stress in endothelial function and blood pressure in patients with OSA. This is a pilot clinical study that will compare oxidative stress parameters, and endothelial function in patients with OSA before starting treatment with continuous positive airway pressure (CPAP) and 12 weeks post being on CPAP. These patients will be compared to control patients with no history of OSA. the study does not involve assignement to different treatments. All patients will receive the indicated treatment for OSA and measurements will be collected before and 12 weeks after adequate treatment.
Read the detailed description
Obstructive Sleep Apnea (OSA) is increasingly recognized as a cardiovascular risk factor. OSA is a cause of hypertension and has strong association with atherosclerosis, coronary heart disease, diabetes stroke , and fatal cardiovascular events. Endothelial dysfunction is a preclinical vascular abnormality that predicts subsequent development of vascular disease . Patients with OSA demonstrate endothelial dysfunction in the absence of any manifested vascular disease . The mechanism of endothelial dysfunction in OSA is largely unknown. Endothelial dysfunction in OSA is reversible with antioxidants, suggesting a role for oxidant overproduction in the decreased NO availability in OSA. This provides parallels to other cardiovascular diseases in which oxidative stress induced endothelial dysfunction is important.
Recent studies reported evidence of dysfunction or decreased expression of endothelial nitric oxide synthase (eNOS) in association with increased peroxynitrite in harvested venous endothelial cells of OSA patients. We endeavored to perform the first direct quantification of microvascular endothelial genes from OSA patients. We hypothesized that patients with OSA who are free of any cardiovascular disease will have early functional changes in the microcirculatory endothelial cells that are associated with OSA, and therefore would resolve with treatment. Given the role of oxidative stress in the vascular disease of OSA, we expected to find evidence of superoxide overproduction in the microcirculatory vessels. We expected these functional changes to be reversible with treatment of OSA.
Measurement of superoxide will be done on the subcutaneous biopsy tissue using quantitative Polymerase Chain Reaction (qPCR) and immunohistochemistry techniques and image analysis software. Measurement of endothelial function will be done using Doppler ultrasound.
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea,, oxidative stress
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group: healthy individuals without OSA | healthy individuals without OSA who are matched in weight and age to the participating OSA patients | |
| OSA group | Patients in the OSA group receive CPAP for 12 weeks as part of their care. patients with OSA provide measures at baseline and after 12 weeks of CPAP treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilation
A non-invasive test using an ultrasound to measure baseline resting vessel diameter and vessel wall dilation in upper arm post application of an inflated blood pressure cuff for five minutes. The percentage change in vessel wall dilation due to stimulation from the resting vessel diameter will be calculated for each group of participants. The results will be compared relative to each group of participants.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startFeb 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rami Khayat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rami Khayat, Ohio State University
- Investigators
- Rami Khayat, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701441
- Sponsor's protocol ID
- 2005H0221
- Status last verified
- Oct 2013
- First submitted
- 15 May 2008
- Last updated
- 30 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Patt BT, Jarjoura D, Haddad DN, Sen CK, Roy S, Flavahan NA, Khayat RN. Endothelial dysfunction in the microcirculation of patients with obstructive sleep apnea. Am J Respir Crit Care Med. 2010 Dec 15;182(12):1540-5. doi: 10.1164/rccm.201002-0162OC. Epub 2010 Jul 23.
PubMed 20656942
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Oxidative Stress in the Cardiovascular Consequences of Sleep Apnea
- ClinicalTrials.gov ID
- NCT00701441
- Acronym / sponsor ID
- 2005H0221
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea,, oxidative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Rami KhayatUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 30 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive Sleep Apnea (OSA) is the most common sleep disorder affecting up to 9-24 percent of middle aged adults, and is becoming increasingly implicated in the pathogenesis of hypertension, and other cardiovascular disorders. Up to half of patients with OSA have hypertension, and their risk of developing hypertension increases with the increasing severity of Sleep Apnea. Patients with OSA and no hypertension have endothelial dysfunction, which is believed to be the precursor for most cardiovascular disorders.
The upper airway collapse and obstruction that occur in OSA result in a pattern of intermittent hypoxia, that has been shown to be the cause of the hypertension, and endothelial dysfunction found in patients with OSA. Intermittent hypoxia results in oxidative stress, which in turn is linked to the pathogenesis of hypertension and endothelial dysfunction.
This protocol evaluates the role of the oxidative stress in endothelial function and blood pressure in patients with OSA. This is a pilot clinical study that will compare oxidative stress parameters, and endothelial function in patients with OSA before starting treatment with continuous positive airway pressure (CPAP) and 12 weeks post being on CPAP. These patients will be compared to control patients with no history of OSA. the study does not involve assignement to different treatments. All patients will receive the indicated treatment for OSA and measurements will be collected before and 12 weeks after adequate treatment.
Detailed description
Obstructive Sleep Apnea (OSA) is increasingly recognized as a cardiovascular risk factor. OSA is a cause of hypertension and has strong association with atherosclerosis, coronary heart disease, diabetes stroke , and fatal cardiovascular events. Endothelial dysfunction is a preclinical vascular abnormality that predicts subsequent development of vascular disease . Patients with OSA demonstrate endothelial dysfunction in the absence of any manifested vascular disease . The mechanism of endothelial dysfunction in OSA is largely unknown. Endothelial dysfunction in OSA is reversible with antioxidants, suggesting a role for oxidant overproduction in the decreased NO availability in OSA. This provides parallels to other cardiovascular diseases in which oxidative stress induced endothelial dysfunction is important.
Recent studies reported evidence of dysfunction or decreased expression of endothelial nitric oxide synthase (eNOS) in association with increased peroxynitrite in harvested venous endothelial cells of OSA patients. We endeavored to perform the first direct quantification of microvascular endothelial genes from OSA patients. We hypothesized that patients with OSA who are free of any cardiovascular disease will have early functional changes in the microcirculatory endothelial cells that are associated with OSA, and therefore would resolve with treatment. Given the role of oxidative stress in the vascular disease of OSA, we expected to find evidence of superoxide overproduction in the microcirculatory vessels. We expected these functional changes to be reversible with treatment of OSA.
Measurement of superoxide will be done on the subcutaneous biopsy tissue using quantitative Polymerase Chain Reaction (qPCR) and immunohistochemistry techniques and image analysis software. Measurement of endothelial function will be done using Doppler ultrasound.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: healthy individuals without OSA | – | –healthy individuals without OSA who are matched in weight and age to the participating OSA patients |
| OSA group | – | –Patients in the OSA group receive CPAP for 12 weeks as part of their care. patients with OSA provide measures at baseline and after 12 weeks of CPAP treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People screened for sleep apnea with a completed sleep study who do not have hypertension or coronary artery disease.
Key inclusion criteria (1 listed)
- Completed sleep study - Older than 18
Key exclusion criteria (8 listed)
- Hypertension
- Diabetes
- coronary disease
- Peripheral vascular disease
- High cholesterol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Flow Mediated Dilation
Time frame: Baseline and 12 weeks
A non-invasive test using an ultrasound to measure baseline resting vessel diameter and vessel wall dilation in upper arm post application of an inflated blood pressure cuff for five minutes. The percentage change in vessel wall dilation due to stimulation from the resting vessel diameter will be calculated for each group of participants. The results will be compared relative to each group of participants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20656942Patt BT, Jarjoura D, Haddad DN, Sen CK, Roy S, Flavahan NA, Khayat RN. Endothelial dysfunction in the microcirculation of patients with obstructive sleep apnea. Am J Respir Crit Care Med. 2010 Dec 15;182(12):1540-5. doi: 10.1164/rccm.201002-0162OC. Epub 2010 Jul 23.
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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.
Rami Khayat, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Rami Khayat at 1 site in United States.
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 1 inclusion and 8 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 30 Oct 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 United States. 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?
Yes. Results are posted in the registry (first posted 30 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Flow Mediated Dilation (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00701441, which also lists 1 linked publication.
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 30 Oct 2013.