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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00957463
First Posted: August 12, 2009
Last Update Posted: December 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The University of Hong Kong
  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:


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 ]

Secondary Outcome Measures:
  • circulatory metabolic and vascular inflammatory biomarkers [ Time Frame: baseline ]

Estimated Enrollment: 150
Study Start Date: June 2008
Primary Completion Date: December 2011 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957463


Locations
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, 852
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Mary SM Ip, MD The University of Hong Kong
  More Information

Publications:
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
First Submitted: August 10, 2009
First Posted: August 12, 2009
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by The University of Hong Kong:
endothelial function

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases