Effects of Obstructive Sleep Apnea and/or Cigarette Smoking on Endothelial Function

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2010 by The University of Hong Kong.
Recruitment status was Recruiting

Sponsor:

Information provided by:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT00957463

First received: August 10, 2009

Last updated: July 1, 2010

Last verified: July 2010

History of Changes

Purpose

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.

Condition
Obstructive Sleep Apnea Smoking

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	Effects of Intermittent Hypoxia and/or Cigarette Smoking on Endothelial Injury in Vivo - Relevance to Obstructive Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Smoking

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:

reactive hyperemia induced peripheral arterial tone (RH-RAT) index [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

circulatory metabolic and vascular inflammatory biomarkers [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	June 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957463

Contacts

Contact: Mary SM Ip, MD	852-28554455	msmip@hkucc.hku.hk
Contact: Macy MS Lui, MRCP	852-73069288	macylui@graduate.hku.hk

Locations

Hong Kong
Queen Mary Hospital	Recruiting
Hong Kong, Hong Kong, 852
Contact: Mary SM Ip, MD 852-28554455 msmip@hkucc.hku.hk
Sub-Investigator: Macy MS Lui, MRCP

Sponsors and Collaborators

The University of Hong Kong

Investigators

Principal Investigator:

Mary SM Ip, MD

The University of Hong Kong

More Information

Publications:

Barnoya J, Glantz SA. Cardiovascular effects of secondhand smoke: nearly as large as smoking. Circulation. 2005 May 24;111(20):2684-98. Review.

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.

Lavie L, Lavie P. Smoking interacts with sleep apnea to increase cardiovascular risk. Sleep Med. 2008 Mar;9(3):247-53. Epub 2007 May 21.

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. Epub 2007 Feb 1.

Bernhard D, Wang XL. Smoking, oxidative stress and cardiovascular diseases--do anti-oxidative therapies fail? Curr Med Chem. 2007;14(16):1703-12. Review.

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 1;28(5):594-600.

Responsible Party:	Professor Mary SM Ip, The University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00957463 History of Changes
Other Study ID Numbers:	UW 08-023
Study First Received:	August 10, 2009
Last Updated:	July 1, 2010
Health Authority:	Hong Kong: Institutional Review board, the University of Hong Kong, Hong Kong West Cluster, Hospital Authority

Keywords provided by The University of Hong Kong:

endothelial function

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Smoking
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Habits

ClinicalTrials.gov processed this record on June 17, 2013

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