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

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT00957463
Collaborator
(none)
150
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    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
    Study Start Date :
    Jun 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. reactive hyperemia induced peripheral arterial tone (RH-RAT) index [baseline]

    Secondary Outcome Measures

    1. circulatory metabolic and vascular inflammatory biomarkers [baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00957463
    Other Study ID Numbers:
    • UW 08-023
    First Posted:
    Aug 12, 2009
    Last Update Posted:
    Dec 30, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 30, 2014