Obstructive Sleep ApneaNCT01828281
Effects of CPAP on Visceral Fat Thickness
A study testing CPAP in people with Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic patients with OSA of apnea hypopnea index (AHI) >= 5/hr
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic CPAP | Active comparator | Therapeutic CPAP Receives: Device: CPAP |
| control | Sham comparator | subtherapeutic CPAP using 4 cm water Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesenteric Fat Thickness
Measured: 3 months
Secondary outcomes (1)
Mean Changes in Adiponectin Over 3 Months
Mean changes in Adiponectin from baseline to 3 months.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof David Shu Cheong Hui, Chinese University of Hong Kong
- Investigators
- Hui David, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828281
- Sponsor's protocol ID
- VF-CPAP
- Status last verified
- Oct 2015
- First submitted
- 8 Apr 2013
- Last updated
- 16 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27933703
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01828281
- Acronym / sponsor ID
- VF-CPAP
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Posted 16 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic CPAP | Active comparator | Device: CPAPTherapeutic CPAP |
| control | Sham comparator | Device: CPAPsubtherapeutic CPAP using 4 cm water |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic patients with OSA of apnea hypopnea index (AHI) >= 5/hr
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPAll 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. | Device | Therapeutic CPAP, control |
Primary outcome
Mesenteric Fat Thickness
Time frame: 3 months
1 secondary outcome
Mean Changes in Adiponectin Over 3 Months
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27933703Ng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui David, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesenteric Fat Thickness (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01828281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.