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

December 29, 2014 updated by: The University of Hong Kong

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong, 852
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reactive hyperemia induced peripheral arterial tone (RH-RAT) index
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
circulatory metabolic and vascular inflammatory biomarkers
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mary SM Ip, MD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking

Subscribe