Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea (OSA/MAFLD)

Association between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea; Metabolic Dysfunction-Associated Steatotic Liver Disease

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 Type: Observational
• Enrollment (Estimated): 127

Contacts and Locations

• Study Contact: Name: Amira Mohamed Abdelmawgod, MD, Assuit University; Phone Number: +201012760437; Email: amiramohmad60@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Patients aged >18 years old
• presented with a clinical suspicion of sleep-disordered breathing, including snoring, sleepiness and witnessed sleep apnea

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 04-2026-300909

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No