FIB-4 Index, Sleep Apnea Severity, and Nocturnal Hypoxemia

NCT07798518 — Completed, 373 participants, Hisar Intercontinental Hospital

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Association of the FIB-4 Index With Obstructive Sleep Apnea Severity and Nocturnal Hypoxemia: A Retrospective Polysomnographic Study

Registry	NCT07798518, acronym FIB-4-OSA
Status	Completed
Study type	Observational
Enrollment	373 (Actual)
Sponsor	Hisar Intercontinental Hospital (Other)
Conditions	Obstructive Sleep Apnea (OSA), Metabolic Dysfunction-Associated Steatotic Liver Disease
Dates	start 2026-01-01, primary completion 2026-07-31, completion 2026-07-31, first posted 2026-09-01, last updated 2026-09-18
Locations	1 site in Turkey (Türkiye)

-Summary

This retrospective study evaluates whether the Fibrosis-4 (FIB-4) index is associated with the severity of obstructive sleep apnea (OSA) and nighttime oxygen desaturation. Adults who underwent full-night polysomnography were grouped according to apnea-hypopnea index (AHI) as no OSA, mild OSA, moderate OSA, or severe OSA. Routine clinical, laboratory, and sleep-study data were reviewed.

The main aim is to compare FIB-4 values across OSA severity groups and to examine whether FIB-4 is related to AHI, oxygen desaturation index (ODI), and minimum oxygen saturation during sleep. The study also evaluates the proportion of patients with FIB-4 values at or above 1.30, a commonly used threshold for identifying individuals who may need further liver fibrosis assessment.

FIB-4 is used in this study as a noninvasive liver fibrosis risk marker and not as a diagnosis of liver fibrosis.

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+Detailed description

This is a single-center, retrospective observational study of adults aged 18-65 years who underwent diagnostic full-night polysomnography. Participants were classified according to the apnea-hypopnea index (AHI) as AHI <5 events/h, mild OSA (5-14.9 events/h), moderate OSA (15-29.9 events/h), or severe OSA (≥30 events/h).

Demographic, polysomnographic, hematologic, and biochemical data were obtained retrospectively from hospital records. Laboratory measurements closest to the polysomnography date within ±30 days were used. The FIB-4 index was calculated from age, aspartate aminotransferase, alanine aminotransferase, and platelet count.

FIB-4 was evaluated as a continuous variable and using clinically established risk thresholds. Associations between FIB-4 and polysomnographic measures, including AHI, oxygen desaturation index (ODI), and minimum peripheral oxygen saturation (SpO₂), were examined. The study also explored the relationship between FIB-4 and the neutrophil-to-lymphocyte ratio (NLR). No study-related intervention was administered.

+Arms and interventions

Arm	Type	Interventions	Description
AHI <5 (Non-OSA)			Participants with an apnea-hypopnea index (AHI) <5 events/hour on full-night polysomnography.
Mild OSA			Participants with AHI 5-14.9 events/hour.
Moderate OSA			Participants with AHI 15-29.9 events/hour.
Severe OSA			Participants with AHI ≥30 events/hour.

+Outcome measures

Primary outcomes

FIB-4 Index Across Obstructive Sleep Apnea Severity Groups [Within 30 days before or after polysomnography]: FIB-4 index was compared across four groups defined by the apnea-hypopnea index (AHI): AHI <5 events/hour, mild OSA (5-14.9 events/hour), moderate OSA (15-29.9 events/hour), and severe OSA (≥30 events/hour).
FIB-4 Index Across Obstructive Sleep Apnea Severity Groups [Within ±30 days of polysomnography]: FIB-4 index will be compared across four OSA severity groups defined by the apnea-hypopnea index (AHI): AHI <5 events/hour, mild OSA (5-14.9 events/hour), moderate OSA (15-29.9 events/hour), and severe OSA (≥30 events/hour). FIB-4 is calculated as age (years) × AST (U/L) / \[platelet count (10⁹/L) × √ALT (U/L)\].

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Adults aged 18-65 years.
* Underwent technically adequate diagnostic full-night polysomnography.
* Sufficient demographic and clinical data available for OSA classification.

Exclusion Criteria:

* Age <18 or >65 years.
* Technically inadequate polysomnography.
* Split-night or positive airway pressure (PAP) titration studies.
* Known advanced chronic liver disease or cirrhosis.
* Hematologic malignancy.
* Active infection.
* Clinically significant systemic inflammatory or autoimmune disease.
* Chemotherapy, radiotherapy, or immunosuppressive therapy.
* Pregnancy.
* Clinically significant alcohol use or alcohol-related liver disease.
* Missing laboratory components required for the relevant FIB-4 or NLR analysis.

+Locations (1)

Facility	City	Country	Status
Hisar Hospital Intercontinental	Istanbul, Istanbul	Turkey (Türkiye)

+Publications

Results publication: Bettini S, Serra R, Fabris R, Dal Pra C, Favaretto F, Dassie F, Duso C, Vettor R, Busetto L. Association of obstructive sleep apnea with non-alcoholic fatty liver disease in patients with obesity: an observational study. Eat Weight Disord. 2022 Feb;27(1):335-343. doi: 10.1007/s40519-021-01182-9. Epub 2021 Apr 3. PMID 33811619
Results publication: Gul S, Ozyurt S, Keklikkiran C, Gumus A. The Relationship Between Chronic Intermittent Hypoxia and MASLD and Fibrosis in Obstructive Sleep Apnea Patients. J Clin Med. 2026 Mar 3;15(5):1911. doi: 10.3390/jcm15051911. PMID 41827328
Results publication: Trzepizur W, Boursier J, Poilane J, Bureau C, Sedkaoui K, Pontier S, Costentin C, Pepin JL, Schnee M, Bizieux A, Guillaume M, Hamel JF, Gagnadoux F. Association between obstructive sleep apnea and liver fibrosis in patients with suspected nonalcoholic fatty liver disease. Sleep. 2026 Feb 10;49(2):zsaf265. doi: 10.1093/sleep/zsaf265. PMID 40884485
Results publication: Mesarwi OA, Loomba R, Malhotra A. Obstructive Sleep Apnea, Hypoxia, and Nonalcoholic Fatty Liver Disease. Am J Respir Crit Care Med. 2019 Apr 1;199(7):830-841. doi: 10.1164/rccm.201806-1109TR. PMID 30422676

+Investigators

Bekir Sami Uyanık, MD,, Principal investigator, Hisar Hospital Intercontinental
Orhan Dalkılıç, MD, Principal investigator, Hisar Hospital Intercontinental
Süleyman Hilmi İpekçi, MD, Principal investigator, Hisar Hospital Intercontinental