NCT07716995

Brief Summary

Association between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 14, 2026

Last Update Submit

July 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Amira Mohamed Abdelmawgod, MD, Assuit University

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer of Tropical Medicine and Gastroenterology

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 21, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

July 22, 2026

Record last verified: 2026-07