Obstructive Sleep Apnea Clinical Trial
Official title:
A Randomized Controlled Study on the Effects of Continuous Positive Airway Pressure (CPAP) on Visceral Fat Thickness, Carotid Intima-media Thickness and Adipokines in Patients With Obstructive Sleep Apnoea Syndrome (OSAS)
We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and liver fat, plasma lipids, carotid artery thickness.
Status | Completed |
Enrollment | 141 |
Est. completion date | August 2015 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - symptomatic patients with OSA of apnea hypopnea index (AHI) >= 5/hr Exclusion Criteria: - Recent or past history of myocardial infarction/stroke/heart failure, unstable angina, underlying malignancy, - patients with clinical features of any active infection - those who require urgent CPAP treatment because of associated respiratory failure or to prevent job loss through excessive daytime sleepiness (eg professional drivers, those handling dangerous machinery) - moderate to severe valvular heart disease, cardiomyopathy, and previous diagnosis of OSA and/or previous use of CPAP therapy. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Respiratory Division | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mean Hours of CPAP Usage Per Day | Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period. | 3 months | No |
Primary | Mesenteric Fat Thickness | 3 months | No | |
Secondary | Mean Changes in Adiponectin Over 3 Months | Mean changes in Adiponectin from baseline to 3 months. | Baseline, 3 months | No |
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