Effects of CPAP on Visceral Fat Thickness

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828281
• Other study ID #: VF-CPAP
• Status: Completed
• Phase: N/A
• First received: April 8, 2013
• Last updated: October 15, 2015
• Start date: February 2012
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This proposed randomized control trial (RCT) will compare the effects of therapeutic CPAP versus subtherapeutic CPAP in patients newly diagnosed with OSA with reference to visceral fat especially mesenteric fat thickness, liver fat, carotid artery intima media thickness (IMT), lateral pharyngeal wall (LPW) thickness, plasma lipids and adipokines over a treatment period of 3 months. The results of this study will advance our understanding of the relative role of OSA and obesity in the pathogenesis of metabolic syndrome (MetS) and whether CPAP therapy can improve these metabolic dysregulation.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
All subjects will undergo ultrasound examination of the abdomen the day after overnight polysomnography (PSG) and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water.

Locations

Country	Name	City	State
China	Respiratory Division	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

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