Association of the FIB-4 Index With Obstructive Sleep Apnea Severity and Nocturnal Hypoxemia: A Retrospective Polysomnographic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- FIB-4 Index Across Obstructive Sleep Apnea Severity Groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years. Underwent technically adequate diagnostic full-night polysomnography. Sufficient demographic and clinical data available for OSA classification.
排除标准
- •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.
研究组 & 干预措施
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.
AHI <5 (Non-OSA)
Participants with an apnea-hypopnea index (AHI) <5 events/hour on full-night polysomnography.
结局指标
主要结局
FIB-4 Index Across Obstructive Sleep Apnea Severity Groups
时间窗: 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
时间窗: 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) / \[platelet count (10⁹/L) × √ALT (U/L)\].
次要结局
未报告次要终点
研究者
Bekir Sami Uyanık
Professor of Clinical Biochemistry
Hisar Intercontinental Hospital