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Effects of CPAP on Visceral Fat Thickness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828281
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : November 16, 2015
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
Prof David Shu Cheong Hui, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: CPAP Not Applicable

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.




Primary Outcome Measures :
  1. Mesenteric Fat Thickness [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Mean Changes in Adiponectin Over 3 Months [ Time Frame: Baseline, 3 months ]
    Mean changes in Adiponectin from baseline to 3 months.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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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
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.

Information from the National Library of Medicine

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


Locations
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China
Respiratory Division
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Hui David, MD Chinese University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases