Obstructive Sleep ApneaOSA/MAFLDNCT07716995
Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Assiut University.
Trial summary
Association between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Adult
Study population: * Patients with a clinical suspicion of sleep-disordered breathing will undergo overnight polysomnography and the followings indices will be recorded(apnea-hypopnea index (AHI); oxygen desaturation index (ODI); lowest arterial oxyhemoglobin saturation during sleep(LaSO2); mean arterial oxyhemoglobin saturation during sleep(mean SpO2); and %sleep time in which SpO2 < 90%.( TS90%). * Diagnosis of MAFLD will made when a patient has BMI >25 kg/m2, T2DM or at least two metabolic risk abnormalities. * All patients will undergo data pertaining to clinical history (name, age, sex, residence, occupation, co-morbidities… diabetes, hyperlipidemia, hypertension, ischemic heart disease, special habits; such as alcohol intake and smoking). * Four anthropometric measurements will be obtained (height, weight, body mass index, waist circumference (WC)). * Blood samples will be collected for doing liver function tests, lipid profile, CBC, HbA1c.
Who may be able to join
- Patients aged >18 years old
- presented with a clinical suspicion of sleep-disordered breathing, including snoring, sleepiness and witnessed sleep apnea
Who cannot join
- Patients aged ≤18 years old
- Pregnancy
- Presence of malignancy
- Type I DM
- Patients with fatty liver who undergone bariatric surgeries.
- Patients with Central sleep apnea, upper airway resistance and narcolepsy
- Patients with lung diseases with hypoxia
- Previous history of alcohol consumption, steroids, proton pump inhibitors, antibiotics, and contraceptive pills
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Association between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
Read the detailed description
Obstructive sleep apnea (OSA) is an increasingly common disorder that is characterized by periodic collapse of the upper airway resulting in cycles of hypoxia and reoxygenation known as chronic intermittent hypoxia(CIH). Evidence has shown that OSA can contribute to the development of many metabolic abnormalities (such as obesity, hyperglycemia, dyslipidemia, and the metabolic syndrome).
Metabolic associated fatty liver disease (MAFLD) has become more common in recent years. MAFLD is thought to be the primary cause of chronic liver disorders, and it has grown to be a significant global public health concern. The prevalence of MAFLD has been steadily rising due to changes in lifestyle and dietary patterns, making it the most common chronic liver ailment globally. The global prevalence of MAFLD is 30.1%.
Evidence emerged that linked OSA severity with the development and progression of MAFLD. For example, CIH (a hallmark of OSA) was identified as an independent risk factor in the onset and progression of MAFLD. The essential links between CIH and MAFLD involve insulin resistance, glucose dysregulation, dysfunction of key steps in hepatic lipid metabolism, oxidative stress, and hepatic steatosis and fibrosis, which together indicate that metabolic dysfunction plays a significant role in the pathogenesis of CIH-associated MAFLD
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Apnea-Hypopnea Index and MASLD
To assess the correlation between the Apnea-Hypopnea Index (AHI), measured by overnight polysomnography (events/hour), and hepatic steatosis measured by FibroScan with Controlled Attenuation Parameter (CAP), reported in decibels per meter (dB/m).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716995
- Sponsor's protocol ID
- 04-2026-300909
- Acronym
- OSA/MAFLD
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07716995
- Acronym / sponsor ID
- OSA/MAFLD / 04-2026-300909
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Jul 2026 (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.
Association between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
Detailed description
Obstructive sleep apnea (OSA) is an increasingly common disorder that is characterized by periodic collapse of the upper airway resulting in cycles of hypoxia and reoxygenation known as chronic intermittent hypoxia(CIH). Evidence has shown that OSA can contribute to the development of many metabolic abnormalities (such as obesity, hyperglycemia, dyslipidemia, and the metabolic syndrome).
Metabolic associated fatty liver disease (MAFLD) has become more common in recent years. MAFLD is thought to be the primary cause of chronic liver disorders, and it has grown to be a significant global public health concern. The prevalence of MAFLD has been steadily rising due to changes in lifestyle and dietary patterns, making it the most common chronic liver ailment globally. The global prevalence of MAFLD is 30.1%.
Evidence emerged that linked OSA severity with the development and progression of MAFLD. For example, CIH (a hallmark of OSA) was identified as an independent risk factor in the onset and progression of MAFLD. The essential links between CIH and MAFLD involve insulin resistance, glucose dysregulation, dysfunction of key steps in hepatic lipid metabolism, oxidative stress, and hepatic steatosis and fibrosis, which together indicate that metabolic dysfunction plays a significant role in the pathogenesis of CIH-associated MAFLD
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- * Patients with a clinical suspicion of sleep-disordered breathing will undergo overnight polysomnography and the followings indices will be recorded(apnea-hypopnea index (AHI); oxygen desaturation index (ODI); lowest arterial oxyhemoglobin saturation during sleep(LaSO2); mean arterial oxyhemoglobin saturation during sleep(mean SpO2); and %sleep time in which SpO2 < 90%.( TS90%). * Diagnosis of MAFLD will made when a patient has BMI >25 kg/m2, T2DM or at least two metabolic risk abnormalities. * All patients will undergo data pertaining to clinical history (name, age, sex, residence, occupation, co-morbidities… diabetes, hyperlipidemia, hypertension, ischemic heart disease, special habits; such as alcohol intake and smoking). * Four anthropometric measurements will be obtained (height, weight, body mass index, waist circumference (WC)). * Blood samples will be collected for doing liver function tests, lipid profile, CBC, HbA1c.
Key inclusion criteria (2 listed)
- Patients aged >18 years old
- presented with a clinical suspicion of sleep-disordered breathing, including snoring, sleepiness and witnessed sleep apnea
Key exclusion criteria (8 listed)
- Patients aged ≤18 years old
- Pregnancy
- Presence of malignancy
- Type I DM
- Patients with fatty liver who undergone bariatric surgeries.
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
Correlation Between Apnea-Hypopnea Index and MASLD
Time frame: At baseline
To assess the correlation between the Apnea-Hypopnea Index (AHI), measured by overnight polysomnography (events/hour), and hepatic steatosis measured by FibroScan with Controlled Attenuation Parameter (CAP), reported in decibels per meter (dB/m).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Assiut University.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Mohamed Abdelmawgod, MD, Assuit University (+201012760437, amiramohmad60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Apnea-Hypopnea Index and MASLD (time frame: At baseline). 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 2 Nov 2026.