Effects of CPAP on Visceral Fat Thickness
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ClinicalTrials.gov Identifier: NCT01828281 |
Recruitment Status :
Completed
First Posted : April 10, 2013
Results First Posted : November 16, 2015
Last Update Posted : November 16, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea | Device: CPAP | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 141 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | February 2012 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Therapeutic CPAP
Therapeutic CPAP
|
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. |
Sham Comparator: control
subtherapeutic CPAP using 4 cm water
|
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. |
- Mesenteric Fat Thickness [ Time Frame: 3 months ]
- Mean Changes in Adiponectin Over 3 Months [ Time Frame: Baseline, 3 months ]Mean changes in Adiponectin from baseline to 3 months.
- Mean Hours of CPAP Usage Per Day [ Time Frame: 3 months ]Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period.

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828281
China | |
Respiratory Division | |
Hong Kong, China |
Principal Investigator: | Hui David, MD | Chinese University of Hong Kong |
Responsible Party: | Prof David Shu Cheong Hui, Professor, Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT01828281 |
Other Study ID Numbers: |
VF-CPAP |
First Posted: | April 10, 2013 Key Record Dates |
Results First Posted: | November 16, 2015 |
Last Update Posted: | November 16, 2015 |
Last Verified: | October 2015 |
Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |