Obstructive Sleep ApneaNCT00957463
Effects of Obstructive Sleep Apnea and/or Cigarette Smoking on Endothelial Function
An observational study of Obstructive Sleep Apnea and Smoking, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The hypothesis of this study is that either obstructive sleep apnea (OSA) or cigarette smoking (CS) exposure would produce oxidative stress and inflammation leading to endothelial injury, and the combined exposure would be additive or synergistic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Smoking
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2008to Dec 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive subjects who undergo polysomnograms (PSG) in the Sleep Disorder Centre, Department of Medicine, Queen Mary Hospital, and who fulfill the study criteria will be recruited.
Who may be able to join
- No acute illness
- No hospitalization in past 4 weeks
- Absence of medical comorbidity such as hypertension, ischemic heart disease, diabetes and hyperlipidemia, renal impairment, vasculitis or Raynaud's syndrome, peripheral vascular disease especially Buerger's disease, aortic disease (aortic aneurysm or dilatation), cancer, thrombocytopenia, coagulation disorder or other chronic medical illness
Who cannot join
- Mentally incapacitated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intermittent Hypoxia and/or Cigarette Smoking on Endothelial Injury in Vivo - Relevance to Obstructive Sleep Apnea
The hypothesis of this study is that either obstructive sleep apnea (OSA) or cigarette smoking (CS) exposure would produce oxidative stress and inflammation leading to endothelial injury, and the combined exposure would be additive or synergistic.
- Conditions
- Obstructive Sleep Apnea, Smoking
- Keywords
- endothelial function
- Medical subject headings
- Sleep Apnea, Obstructive, Smoking
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 |
|---|---|---|
| smoker, with high apnea-hypopnea index | subjects who smoke either in the past or currently, with confirmed moderate-severe OSA | |
| smoker, mild OSA or without OSA | subjects who smoke either in the past or currently, with mild OSA or without OSA | |
| nonsmoker, with high apnea-hypopnea index | subjects who never smoke, with confirmed moderate-severe OSA | |
| nonsmoker, with mild OSA or without OSA | subjects who never smoke, with mild OSA or without OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
reactive hyperemia induced peripheral arterial tone (RH-RAT) index
Measured: baseline
Secondary outcomes (1)
circulatory metabolic and vascular inflammatory biomarkers
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Mary SM Ip, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957463
- Sponsor's protocol ID
- UW 08-023
- Status last verified
- Dec 2014
- First submitted
- 10 Aug 2009
- Last updated
- 30 Dec 2014
- Results posted
- No
Publications
Barnoya J, Glantz SA. Cardiovascular effects of secondhand smoke: nearly as large as smoking. Circulation. 2005 May 24;111(20):2684-98. doi: 10.1161/CIRCULATIONAHA.104.492215.
PubMed 15911719Kashyap R, Hock LM, Bowman TJ. Higher prevalence of smoking in patients diagnosed as having obstructive sleep apnea. Sleep Breath. 2001 Dec;5(4):167-72. doi: 10.1007/s11325-001-0167-5.
PubMed 11868156Lavie L, Lavie P. Smoking interacts with sleep apnea to increase cardiovascular risk. Sleep Med. 2008 Mar;9(3):247-53. doi: 10.1016/j.sleep.2007.03.018. Epub 2007 May 21.
PubMed 17513169El Solh AA, Akinnusi ME, Baddoura FH, Mankowski CR. Endothelial cell apoptosis in obstructive sleep apnea: a link to endothelial dysfunction. Am J Respir Crit Care Med. 2007 Jun 1;175(11):1186-91. doi: 10.1164/rccm.200611-1598OC. Epub 2007 Feb 1.
PubMed 17272785Bernhard D, Wang XL. Smoking, oxidative stress and cardiovascular diseases--do anti-oxidative therapies fail? Curr Med Chem. 2007;14(16):1703-12. doi: 10.2174/092986707781058959.
PubMed 17627508Itzhaki S, Lavie L, Pillar G, Tal G, Lavie P. Endothelial dysfunction in obstructive sleep apnea measured by peripheral arterial tone response in the finger to reactive hyperemia. Sleep. 2005 May;28(5):594-600. doi: 10.1093/sleep/28.5.594.
PubMed 16171272
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Hypoxia and/or Cigarette Smoking on Endothelial Injury in Vivo - Relevance to Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00957463
- Acronym / sponsor ID
- UW 08-023
- Conditions
- Obstructive Sleep Apnea, Smoking
- Keywords
- endothelial function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2011 (actual)
- First posted
- 12 Aug 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 hypothesis of this study is that either obstructive sleep apnea (OSA) or cigarette smoking (CS) exposure would produce oxidative stress and inflammation leading to endothelial injury, and the combined exposure would be additive or synergistic.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| smoker, with high apnea-hypopnea index | – | –subjects who smoke either in the past or currently, with confirmed moderate-severe OSA |
| smoker, mild OSA or without OSA | – | –subjects who smoke either in the past or currently, with mild OSA or without OSA |
| nonsmoker, with high apnea-hypopnea index | – | –subjects who never smoke, with confirmed moderate-severe OSA |
| nonsmoker, with mild OSA or without OSA | – | –subjects who never smoke, with mild OSA or without OSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive subjects who undergo polysomnograms (PSG) in the Sleep Disorder Centre, Department of Medicine, Queen Mary Hospital, and who fulfill the study criteria will be recruited.
Key inclusion criteria (3 listed)
- No acute illness
- No hospitalization in past 4 weeks
- Absence of medical comorbidity such as hypertension, ischemic heart disease, diabetes and hyperlipidemia, renal impairment, vasculitis or Raynaud's syndrome, peripheral vascular disease especially Buerger's disease, aortic disease (aortic aneurysm or dilatation), cancer, thrombocytopenia, coagulation disorder or other chronic medical illness
Key exclusion criteria (1 listed)
- Mentally incapacitated
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
reactive hyperemia induced peripheral arterial tone (RH-RAT) index
Time frame: baseline
1 secondary outcome
circulatory metabolic and vascular inflammatory biomarkers
Time frame: baseline
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 30 Dec 2014.
- Background: PubMed 15911719Barnoya J, Glantz SA. Cardiovascular effects of secondhand smoke: nearly as large as smoking. Circulation. 2005 May 24;111(20):2684-98. doi: 10.1161/CIRCULATIONAHA.104.492215.
- Background: PubMed 11868156Kashyap R, Hock LM, Bowman TJ. Higher prevalence of smoking in patients diagnosed as having obstructive sleep apnea. Sleep Breath. 2001 Dec;5(4):167-72. doi: 10.1007/s11325-001-0167-5.
- Background: PubMed 17513169Lavie L, Lavie P. Smoking interacts with sleep apnea to increase cardiovascular risk. Sleep Med. 2008 Mar;9(3):247-53. doi: 10.1016/j.sleep.2007.03.018. Epub 2007 May 21.
- Background: PubMed 17272785El Solh AA, Akinnusi ME, Baddoura FH, Mankowski CR. Endothelial cell apoptosis in obstructive sleep apnea: a link to endothelial dysfunction. Am J Respir Crit Care Med. 2007 Jun 1;175(11):1186-91. doi: 10.1164/rccm.200611-1598OC. Epub 2007 Feb 1.
- Background: PubMed 17627508Bernhard D, Wang XL. Smoking, oxidative stress and cardiovascular diseases--do anti-oxidative therapies fail? Curr Med Chem. 2007;14(16):1703-12. doi: 10.2174/092986707781058959.
- Background: PubMed 16171272Itzhaki S, Lavie L, Pillar G, Tal G, Lavie P. Endothelial dysfunction in obstructive sleep apnea measured by peripheral arterial tone response in the finger to reactive hyperemia. Sleep. 2005 May;28(5):594-600. doi: 10.1093/sleep/28.5.594.
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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.
Mary SM Ip, MD principal investigator
The University of Hong Kong
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 Obstructive Sleep Apnea and Smoking, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 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 Dec 2014. 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 Hong Kong. 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?
reactive hyperemia induced peripheral arterial tone (RH-RAT) index (time frame: baseline). 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 NCT00957463, which also lists 6 linked publications.
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 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.