The Academic Research Project Studies the Relationship Between Obstructive Sleep Apnoea and the Occurrence of Nocturia.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the parameters of sleep apnoea - time under 90% saturation (T90)
研究概览
简要总结
The main goal of the study is to explore the relationship between obstructive sleep apnoea and nocturia.
详细描述
The observation study will be performed on patients diagnosed with obstructive sleep apnoea. Patients will undergo routine examination for sleep apnoea and will be asked to fill in voiding diaries for 48 hours. The main goal of the study is to find whether there are any parameters of sleep apnoea associated with occurrence of the nocturia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •patients diagnosed obstructive sleep apnoea (OSA )
- •Apnea-Hypopnea Index (AHI) > 15
- •ability to fill in the voiding diaries
- •signed informed consent
排除标准
- •patients using diuretics
- •patients with malignancies
- •pregnancy
结局指标
主要结局
Change in the parameters of sleep apnoea - time under 90% saturation (T90)
时间窗: 3 months
The change in parameters of sleep apnoea - time under 90% saturation (T90) will be monitored from the baseline to the end of follow-up, before and after the treatment intervention for correction of obstructive sleep apnoea (OSA). The obtained data will be correlated with the information from the voiding diary. T90 was defined as the proportion of cumulative sleep time with oxygen saturation below 90% in total sleep time. T90≤5% of the total sleep time was classified as light hypoxia, T90 of 5-10% as mild hypoxia,10-25% as moderate hypoxia, and \>25% as severe hypoxia.
Change in the parameters of sleep apnoea - (apnea-hypopnea index - AHI)
时间窗: 3 months
The change in parameters of sleep apnoea - apnea-hypopnea index (AHI) will be monitored from the baseline to the end of follow-up, before and after the treatment intervention for correction of obstructive sleep apnoea (OSA). The obtained data will be correlated with the information from the voiding diary. The apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep. According to the American Academy of Sleep Medicine (AASM) it is categorized into mild (5-15 events/hour), moderate (15-30 events/hour), and severe (\> 30 events/hour).ollow-up, before and after the treatment intervention for correction of obstructive sleep apnoea (OSA). The obtained data will be correlated with the information from the voiding diary.
Change in the parameters of sleep apnoea - oxygen desaturation index (ODI)
时间窗: 3 months
The change in parameters of sleep apnoea - oxygen desaturation index (ODI) will be monitored from the baseline to the end of follow-up, before and after the treatment intervention for correction of obstructive sleep apnoea (OSA). The obtained data will be correlated with the information from the voiding diary. ODI refers to the average number of desaturation episodes occurring per hour, where desaturation episodes are defined as a decrease in the mean oxygen saturation of ≥3% (over the last 120 seconds) that lasts for at least 10 seconds.
次要结局
- Change in the data from the voiding diary - functional capacity of the bladder(3 months)
- Change in the data from the voiding diary - daily diuresis(3 months)
- Change in the data from the voiding diary - number of voiding episodes(3 months)