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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Non-alcoholic Fatty Liver Disease Among Non-obese Obstructive Sleep Apnea by Using Transient Elastography
- ClinicalTrials.gov ID
- NCT05351515
- Acronym / sponsor ID
- OSA-fattyliver2
- Conditions
- Sleep Apnea, Obstructive, Fatty Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 861 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- aged 18 years or more
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of subjects found to have fatty liver disease among obese patients with obstructive sleep apnea
Time frame: baseline
Number of subjects found to have fatty liver disease among non-obese patients with obstructive sleep apnea
Time frame: baseline
3 secondary outcomes
Number of subjects found to have fatty liver disease among obese subjects without obstructive sleep apnea
Time frame: baseline
Number of subjects found to have fatty liver disease among non-obese subjects without obstructive sleep apnea
Time frame: baseline
mesenteric fat thickness by ultrasound scan of all subjects
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
David Hui study chair
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?
An observational study of Sleep Apnea, Obstructive and Fatty Liver, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 20 Oct 2026. 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 Hong Kong. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects found to have fatty liver disease among obese patients with obstructive sleep apnea (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.