A Pilot, Phase 4, Sleep Laboratory Study Comparing the Physiology of Nocturnal Bladder Function in Subjects With Overactive Bladder - Associated Nocturia to Subjects With Primary Insomnia and Healthy Normal Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Number and proportion of voids associated with urgency
研究概览
简要总结
This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary. After one week, subjects meeting eligibility requirements will complete a single sleep night stay in a sleep laboratory setting. During the sleep night stay, subjects will be evaluated using cystometry and polysomnography. In the morning following the sleep night stay, subjects will complete a sleep questionnaire and this will complete their participation in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must not have a urinary tract infection
- •Time in bed between 6.5 and 9 hours for at least 5 nights per week for preceding month
- •Usual bed time is before midnight (24:00 hours) and typically does not vary by ± 1 hour for preceding month
- •OAB subjects
- •OAB symptoms for >= 3 months
- •Documented detrusor overactivity episodes within 6 months
- •Insomnia subjects
- •Diagnosis of chronic primary insomnia
- •History of > 1 month of waking up more than 2 times per night and being awake for more than 60 minutes per night for at least 3 months
排除标准
- •Diagnosis of both OAB and primary insomnia
- •Diagnosis of nocturnal polyuria
- •Diagnosis of BPH
- •BMI >= 34
结局指标
主要结局
Number and proportion of voids associated with urgency
时间窗: During night in sleep lab
Number and proportion of voids associated with Detrusor Overactivity episodes within 10 minutes prior to the polysomnography (PSG) awakenings
时间窗: During night in sleep lab
Time from PSG awakening to each void in minutes
时间窗: During night in sleep lab
次要结局
未报告次要终点