NCT01481636已完成不适用
Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The purpose of this study is to investigate the correlation between health outcomes associated with the severity of obstructive sleep apnea (OSA) symptomatology, the findings will guide the design of interventional studies.
详细描述
Obstructive sleep apnea is a condition characterised by periods of narrowing of the pharyngeal airways during sleep causing hypoxic and hypercapnic episodes with the cessation of ventilation. Considering the high number of overweight and obese individuals in Western society the understanding of the pathomechanisms behind OSA are important. This observational study aims to investigate the correlations between the severity of Obstructive Sleep Apnea assessed by the apnea-hypopnea index (AHI) and different health outcomes associated with the OSA.
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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index ≤39
- •Not received any treatment for Obstructive Sleep Apnea.
- •Is a non-smoker
- •Is not epileptic
- •Epworth Sleepiness Scale ≥
- •Patient's on Statins or antihypertensive drugs are included as so frequent in OSA.
排除标准
- •Body Mass Index ≥
- •Presence of significant or unstable Renal, Liver or Heart Failure.
- •Receiving anti-diabetic treatment.
- •Is a smoker.
- •Is epileptic
- •Presence of significant or unstable psychological morbidities.
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: one night within four weeks of study.
AHI refers to how is the number of apneas and hypopneas per an hour of sleep.
次要结局
- Residual volume(Within four weeks of recruitment prior to CPAP treatment)
- Plasma 2-arachidonoylglycerol (2-AG)(Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.)
- Plasma Anandamide (ANA)(Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment)
- Insulin(Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment)
- Fat mass(Within four weeks of recruitment prior to CPAP treatment)
- Plasma oleoylethanolamine (OEA)(Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment)
- Plasma C-reactive Protein(Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment)
- Weight(Within four weeks of recruitment prior to CPAP treatment)
- Fat-free mass(Within four weeks of recruitment prior to CPAP treatment)
- Chest RPE(Within four weeks of recruitment prior to CPAP treatment)
- Ventilation with 25% O2/ 6% CO2(Within four weeks of recruitment prior to CPAP treatment)
- Airway Resistance(Within four weeks of recruitment prior to CPAP treatment)
- Plasma Leptin(Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment)
- Neck circumference(Within four weeks of recruitment prior to CPAP treatment)
- Ventilation with 13% O2 / 6% CO2(Within four weeks of recruitment prior to CPAP treatment)
- Mean RR interval(Within four weeks of recruitment prior to CPAP treatment)
- LF/HF ratio(Within four weeks of recruitment prior to CPAP treatment.)
- Plasma Adiponectin(Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment)
- Dyspnea(Within four weeks of recruitment prior to CPAP treatment)
- Functional residual volume(Within four weeks of recruitment prior to CPAP treatment)
- Total lung capacity(Within four weeks of recruitment prior to CPAP treatment)
- Forced Vital capacity(Within four weeks of recruitment prior to CPAP treatment)
- Forced expiratory volume in one second (FEV1)(Within four weeks of recruitment prior to CPAP treatment)
- Waist circumference(Within four weeks of recruitment prior to CPAP treatment)
- Hip circumference(Within four weeks of recruitment prior to CPAP treatment)
- Maximal Inspiratory pressure(Within four weeks of recruitment prior to CPAP treatment)
- Rate of inspiratory muscle fatigue(Within four weeks of recruitment prior to CPAP treatment)
- Ventilation with 13% O2(Within four weeks of recruitment prior to CPAP treatment)
- SDNN(Within four weeks of recruitment prior to CPAP treatment)
- Low frequency domain(Within four weeks of recruitment prior to CPAP treatment.)
- High frequency domain(Within four weeks of recruitment prior to CPAP treatment.)
- NN50 count(Within four weeks of recruitment prior to CPAP treatment)
- NN50 of total HR (%)(Within four weeks of recruitment prior to CPAP treatment)
- HRV triangular index(Within four weeks of recruitment prior to CPAP treatment)
研究者
研究点 (1)
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