An observational study in Obstructive Sleep Apnea (OSA) and Metabolic Dysfunction-Associated Steatotic Liver Disease, sponsored by Hisar Intercontinental Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Hisar Intercontinental Hospital · Observational
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.
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 373 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Hisar Intercontinental Hospital is the lead sponsor of 19 studies on the registry; none are open to participants now.
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The study population consisted of adults aged 18-65 years who underwent diagnostic full-night polysomnography for evaluation of suspected sleep-disordered breathing. Eligible participants were identified retrospectively from hospital records and classified according to the apnea-hypopnea index (AHI) as AHI \<5 events/hour, mild OSA (5-14.9 events/hour), moderate OSA (15-29.9 events/hour), or severe OSA (≥30 events/hour).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with an apnea-hypopnea index (AHI) \<5 events/hour on full-night polysomnography.
Participants with AHI 5-14.9 events/hour.
Participants with AHI 15-29.9 events/hour.
Participants with AHI ≥30 events/hour.
FIB-4 Index Across Obstructive Sleep Apnea Severity Groups
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).
Time frame: Within 30 days before or after polysomnography
FIB-4 Index Across Obstructive Sleep Apnea Severity Groups
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) / \[platelet count (10⁹/L) × √ALT (U/L)\].
Time frame: Within ±30 days of polysomnography
Plan to share: No — Individual participant data (IPD) are not planned to be publicly shared because the study is based on retrospective hospital records containing potentially sensitive clinical information. De-identified data may be made available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
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Hisar Intercontinental Hospital