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Long Term Cardiovascular Complications in Men With Obstructive Sleep Apnea

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by The University of Hong Kong.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Lam Jamie Chung Mei, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01475682
First received: November 16, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose
Subjects with Obstructive Sleep Apnea (OSA) are at increased risk of developing cardiometabolic complications, and effective long-term nCPAP treatment significantly reduces the risk of cardiovascular morbidity and mortality.

Condition
Obstructive Sleep Apnea
Cardiovascular Diseases
Metabolic Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Cardiovascular Complications in Men With Obstructive Sleep Apnea - Prospective 9 Years Follow-up Study

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Incidence of cardiometabolic complications [ Time Frame: 9 years ] [ Designated as safety issue: No ]
    167 subjects recruited from our previous "OSA and metabolic syndrome" (OSAMS) cohort from October 2002 to June 2007 will be invited to be reassessed at this time point.


Secondary Outcome Measures:
  • Effects of CPAP treatment on cardiometabolic conditions [ Time Frame: 9 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 167
Study Start Date: November 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
167 subjects recruited from our previous "OSA and metabolic syndrome" (OSAMS) cohort from October 2002 to June 2007 will be invited to be reassessed at this time point.

Detailed Description:
  1. Primary outcome:

    Incidence of cardiometabolic diseases in subjects with OSA over 9 years.

  2. Secondary outcomes:

Effects of CPAP treatment on cardiometabolic conditions

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
167 subjects recruited from our previous "OSA and metabolic syndrome" (OSAMS) cohort from October 2002 to June 2007 will be invited to be reassessed at this time point.
Criteria

Inclusion Criteria:

  • From previous cohort for reassessment.

Exclusion Criteria:

  • Unstable medical conditions
  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: NCT01475682

Locations
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Jamie C Lam, MD The University of Hong Kong
  More Information

Responsible Party: Lam Jamie Chung Mei, Honorary Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01475682     History of Changes
Other Study ID Numbers: UW 10-002 
Study First Received: November 16, 2011
Last Updated: July 16, 2014
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Obstructive sleep apnea
cardiometabolic complications
Effects of CPAP treatment

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

ClinicalTrials.gov processed this record on December 07, 2016