NCT00957463

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

3.5 years

First QC Date

August 10, 2009

Last Update Submit

December 29, 2014

Conditions

Keywords

endothelial function

Outcome Measures

Primary Outcomes (1)

  • reactive hyperemia induced peripheral arterial tone (RH-RAT) index

    baseline

Secondary Outcomes (1)

  • circulatory metabolic and vascular inflammatory biomarkers

    baseline

Study Arms (4)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Mentally incapacitated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, 852, Hong Kong

Location

Related Publications (6)

  • Barnoya J, Glantz SA. Cardiovascular effects of secondhand smoke: nearly as large as smoking. Circulation. 2005 May 24;111(20):2684-98. doi: 10.1161/CIRCULATIONAHA.104.492215.

    PMID: 15911719BACKGROUND
  • 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. doi: 10.1007/s11325-001-0167-5.

    PMID: 11868156BACKGROUND
  • Lavie L, Lavie P. Smoking interacts with sleep apnea to increase cardiovascular risk. Sleep Med. 2008 Mar;9(3):247-53. doi: 10.1016/j.sleep.2007.03.018. Epub 2007 May 21.

    PMID: 17513169BACKGROUND
  • 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. doi: 10.1164/rccm.200611-1598OC. Epub 2007 Feb 1.

    PMID: 17272785BACKGROUND
  • Bernhard D, Wang XL. Smoking, oxidative stress and cardiovascular diseases--do anti-oxidative therapies fail? Curr Med Chem. 2007;14(16):1703-12. doi: 10.2174/092986707781058959.

    PMID: 17627508BACKGROUND
  • 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;28(5):594-600. doi: 10.1093/sleep/28.5.594.

    PMID: 16171272BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSmoking

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBehavior

Study Officials

  • Mary SM Ip, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 12, 2009

Study Start

June 1, 2008

Primary Completion

December 1, 2011

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations