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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
  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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014