Clinical trial NCT00957463: Effects of Obstructive Sleep Apnea and/or Cigarette Smoking on Endothelial Function
Official title: Effects of Intermittent Hypoxia and/or Cigarette Smoking on Endothelial Injury in Vivo - Relevance to Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Smoking
Keywords: endothelial function
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2009-08-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Mentally incapacitated

Primary outcomes:
measure: reactive hyperemia induced peripheral arterial tone (RH-RAT) index
timeFrame: baseline
Secondary outcomes:
measure: circulatory metabolic and vascular inflammatory biomarkers
timeFrame: baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Mary SM Ip, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kashyap 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.
citation: Lavie 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.
citation: El 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.
citation: Bernhard 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.
citation: Itzhaki 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.