Non-Alcoholic Fatty Liver DiseaseNCT00730873
Fatty Liver and Obstructive Sleep Apnea
A study testing Continuous positive airway pressure in people with Non-Alcoholic Fatty Liver Disease and Obstructive Sleep Apnea, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities in liver enzymes can improve following continuous positive airway pressure in patients with obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Obstructive Sleep Apnea
- What is being tested?
- Continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obstructive sleep apnea, defined as AHI>5/h
Who cannot join
- Consumption of more than 20 grams of alcohol per 24 h
- Known autoimmune disease
- Usage of known hepatotoxic drugs
- Medical history positive for viral hepatitis or other chronic liver disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
The pulmonary institute, Asaf Harofeh Medical Center
Tsrifin, 70300
About this study
Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities in liver enzymes can improve following continuous positive airway pressure in patients with obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes. We hypothesize that continuous positive airway pressure can reduce morphologic fatty liver changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this reduction can be evident using computerized tomography
- Being tested
- Continuous positive airway pressure
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | continuous positive airway pressure Receives: Device: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in fatty liver changes on computerized tomography
Measured: Within 1-2 years
Secondary outcomes (1)
Improved liver enzymes abnormalities
Measured: Within 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730873
- Sponsor's protocol ID
- 135/07
- Status last verified
- Aug 2008
- First submitted
- 6 Aug 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Liver and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00730873
- Acronym / sponsor ID
- 135/07
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- First posted
- 8 Aug 2008 (estimated)
- 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.
Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities in liver enzymes can improve following continuous positive airway pressure in patients with obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes. We hypothesize that continuous positive airway pressure can reduce morphologic fatty liver changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this reduction can be evident using computerized tomography
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Continuous positive airway pressurecontinuous positive airway pressure |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obstructive sleep apnea, defined as AHI>5/h
Key exclusion criteria (4 listed)
- Consumption of more than 20 grams of alcohol per 24 h
- Known autoimmune disease
- Usage of known hepatotoxic drugs
- Medical history positive for viral hepatitis or other chronic liver disease
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 |
|---|---|---|
| Continuous positive airway pressure | Device | A |
Primary outcome
Reduction in fatty liver changes on computerized tomography
Time frame: Within 1-2 years
1 secondary outcome
Improved liver enzymes abnormalities
Time frame: Within 1-2 years
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 8 Aug 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure in people with Non-Alcoholic Fatty Liver Disease and Obstructive Sleep Apnea, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 8 Aug 2008. 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 Israel. 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?
Reduction in fatty liver changes on computerized tomography (time frame: Within 1-2 years). 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 8 Aug 2008; AzTrials last refreshed its copy on 2 Nov 2026.