Sleep Apnea, ObstructiveNCT05351515
Prevalence of Non-alcoholic Fatty Liver Disease Among Non-obese Obstructive Sleep Apnea by Using Transient Elastography
An observational study of Sleep Apnea, Obstructive and Fatty Liver, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Obstructive sleep apnea (OSA) and non-alcoholic fatty liver disease (NAFLD) are both common diseases related to metabolic diseases with potential cardiovascular consequences and liver complications respectively. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Fatty Liver
- How many people
- 861 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Jan 2022to 31 Jul 2026
- Phase
- Observational
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: It is proposed to recruit consecutive patients who have been referred to the Respiratory Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing. In order to invite subjects without symptoms of sleep apnea, collaboration with the Jockey Club School of Public Health and Primary Care, CUHK, to engage healthy volunteers.
Who may be able to join
- aged 18 years or more
Who cannot join
- underlying cause of liver disease
- history of excessive alcoholic consumption (more than 30 g/day for men and 20 g/day for women)
- secondary causes of hepatic steatosis (such as chronic use of systemic corticosteroids)
- positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or histological evidence of other concomitant chronic liver diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Obstructive sleep apnea (OSA) and non-alcoholic fatty liver disease (NAFLD) are both common diseases related to metabolic diseases with potential cardiovascular consequences and liver complications respectively. Though studies show OSA may take part in the progression of hepatic steatosis, the independent contribution of OSA on liver fat accumulation is unknown. It is hypothesized that nocturnal intermittent hypoxia from OSA is the main driver of NAFLD in non-obese OSA patients. This study is to assess the effect of OSA on NAFLD in non-obese patients.
- Conditions
- Sleep Apnea, Obstructive, Fatty Liver
- Medical subject headings
- Sleep Apnea, Obstructive, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects found to have fatty liver disease among obese patients with obstructive sleep apnea
Measured: baseline
Number of subjects found to have fatty liver disease among non-obese patients with obstructive sleep apnea
Measured: baseline
Secondary outcomes (3)
Number of subjects found to have fatty liver disease among obese subjects without obstructive sleep apnea
Measured: baseline
Number of subjects found to have fatty liver disease among non-obese subjects without obstructive sleep apnea
Measured: baseline
mesenteric fat thickness by ultrasound scan of all subjects
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start10 Jan 2022
- Primary completion10 Nov 2025
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 861 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
- David Hui, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351515
- Sponsor's protocol ID
- OSA-fattyliver2
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No