NCT01828281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 16, 2015

Completed
Last Updated

November 16, 2015

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

April 8, 2013

Results QC Date

August 13, 2015

Last Update Submit

October 15, 2015

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Mesenteric Fat Thickness

    3 months

Secondary Outcomes (1)

  • Mean Changes in Adiponectin Over 3 Months

    Baseline, 3 months

Other Outcomes (1)

  • Mean Hours of CPAP Usage Per Day

    3 months

Study Arms (2)

Therapeutic CPAP

ACTIVE COMPARATOR

Therapeutic CPAP

Device: CPAP

control

SHAM COMPARATOR

subtherapeutic CPAP using 4 cm water

Device: CPAP

Interventions

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.

Therapeutic CPAPcontrol

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic patients with OSA of apnea hypopnea index (AHI) \>= 5/hr

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Division

Hong Kong, China

Location

Related Publications (1)

  • 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.

    PMID: 27933703DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Prof David SC Hui
Organization
Chinese University of Hong Kong
dschui@cuhk.edu.hk
2632 3134

Study Officials

  • Hui David, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 10, 2013

Study Start

February 1, 2012

Primary Completion

October 1, 2013

Study Completion

August 1, 2015

Last Updated

November 16, 2015

Results First Posted

November 16, 2015

Record last verified: 2015-10

Locations

CN(1)