Back to resultsEffects of CPAP on Visceral Fat Thickness
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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.
Sites / Locations
- Respiratory Division
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Therapeutic CPAP
control
Arm Description
Therapeutic CPAP
subtherapeutic CPAP using 4 cm water
Outcomes
Primary Outcome Measures
Mesenteric Fat Thickness
Secondary Outcome Measures
Mean Changes in Adiponectin Over 3 Months
Mean changes in Adiponectin from baseline to 3 months.
Full Information
NCT ID
NCT01828281
First Posted
April 8, 2013
Last Updated
October 15, 2015
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01828281
Brief Title
Effects of CPAP on Visceral Fat Thickness
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic CPAP
Arm Type
Active Comparator
Arm Description
Therapeutic CPAP
Arm Title
control
Arm Type
Sham Comparator
Arm Description
subtherapeutic CPAP using 4 cm water
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mesenteric Fat Thickness
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean Changes in Adiponectin Over 3 Months
Description
Mean changes in Adiponectin from baseline to 3 months.
Time Frame
Baseline, 3 months
Other Pre-specified Outcome Measures:
Title
Mean Hours of CPAP Usage Per Day
Description
Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui David, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory Division
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
27933703
Citation
Ng SS, Liu EK, Ma RC, Chan TO, To KW, Chan KK, Ngai J, Yip WH, Ko FW, Wong CK, Hui DS. Effects of CPAP therapy on visceral fat thickness, carotid intima-media thickness and adipokines in patients with obstructive sleep apnoea. Respirology. 2017 May;22(4):786-792. doi: 10.1111/resp.12963. Epub 2016 Dec 9.
Results Reference
derived
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Effects of CPAP on Visceral Fat Thickness
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