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
Moderate OSA
Participants with AHI 15-29.9 events/hour.
Severe OSA
Participants with AHI ≥30 events/hour.
Mild OSA
Participants with AHI 5-14.9 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