Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Obstructive Sleep Apnea
研究概览
简要总结
The purpose of the study is to compare the relative contribution of systemic inflammation vs. Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep apnea.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate OSA (5≤ AHI <30)
- •Men & Women
排除标准
- •Current use of steroids or anti-inflammatory medication
- •Diagnosis of insulin dependent diabetes
- •Diagnosis of autoimmune disorder
- •Shiftwork
- •Current use of CPAP
结局指标
主要结局
Obstructive Sleep Apnea
时间窗: baseline
AHI from one night polysomnography
Presence of the metabolic syndrome
时间窗: baseline
At least 3 of the following 5 risk factors must be met in order to have the metabolic syndrome: 1. Elevated waist measurement (≥102 cm for men or ≥89 cm for women) 2. Elevated triglycerides (≥150 mg/dL or use of medication) 3. Low HDL cholesterol (\<50 mg/dL for women or \<40 mg/dL for men or use of medication) 4. Elevated blood pressure (≥130 mmHg systolic or ≥ 85 mmHg diastolic or use of medication) 5. Elevated fasting blood sugar (≥100 mg/dL or use of medication) Source: https://www.nhlbi.nih.gov/health/health-topics/topics/ms
Markers of systemic inflammation
时间窗: baseline
CRP, IL-6, TNFa
次要结局
- Subjective measure of sleepiness(baseline)
- Heart rate variability(baseline)
研究者
Alexandros Vgontzas
Professor
Milton S. Hershey Medical Center