A Double-blind, Randomised, Parallel-group Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated With Desmopressin Orally Disintegrating Tablets as Compared to Placebo
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Wake after sleep onset
研究概览
简要总结
This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 2 night time voids per night
- •Habitual sleep of 6-9.5 hours per night
- •Experiencing symptoms of Nocturia greater than 6 months
排除标准
- •Greater than 10 night time voids
- •History of sleep apnoea and PLMS (Periodic Limb Movements of Sleep)
- •Other sleep disorders
- •Signs or symptoms of: Bladder outlet obstruction, severe lower urinary tract symptoms (LUTS), interstitial cystitis, moderate to severe overactive bladder (OAB), moderate to severe as judged by the investigator stress urinary incontinence
- •Urological malignancies
- •Neurogenic detrusor over activity (e.g. Parkinson, spinal cord damage, etc.)
- •Central or nephrogenic diabetes insipidus
- •Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40ml/Kg/24hrs)
- •Syndrome of inappropriate antidiuretic hormone (SIADH)
- •Cardiac failure evidence based on physical examination, cardiac medical history and electrocardiogram (ECG) output
- •Uncontrolled hypertension
- •Uncontrolled diabetes mellitus
- •Hyponatraemia with sodium <135 mmol/L
- •Renal insufficiency
- •Known or suspected clinically significant hepatic and/or biliary diseases
研究组 & 干预措施
Experimental A
干预措施: Desmopressin (Drug)
Experimental B
干预措施: Desmopressin (Drug)
Placebo
干预措施: Placebo (not active) (Drug)
结局指标
主要结局
Wake after sleep onset
时间窗: 1 month and 3 months
i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography
Mean number of nocturnal voids
时间窗: 1 month and 3 months
As measured by voiding diary
Sleep efficiency
时间窗: 1 month and 3 months
Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography
Sleep stage N1, N2, N3, (sleep stages in NREM (non-rapid eye movement) and REM (rapid eye movement) as a percentage of total sleep time
时间窗: 1 month and 3 months
Measured by Polysomnography
Number of awakenings due to nocturia
时间窗: 1 month and 3 months
Measured by Actigraphy
Latency to slow-wave sleep
时间窗: 1 month and 3 months
Measured by Polysomnography
Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale
时间窗: 1 month and 3 months
Daytime performance
Mean time to first void
时间窗: 1 month and 3 months
As measured by voiding diary
Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset
时间窗: 1 month and 3 months
Measured by Actigraphy
Percent of sleep
时间窗: 1 month and 3 months
Measured by Actigraphy
Quality of life score measured by EQ-5D-5L
时间窗: 1 month and 3 months
Daytime performance
Safety - incidence of adverse events
时间窗: 1 month and 3 months
Safety - clinically significant changes in lab values
时间窗: 1 week and 3 months
Safety - clinically significant changes in vital signs
时间窗: 1 week, 1 month and 3 months
Safety - clinically significant changes in physical examination
时间窗: 3 months
次要结局
未报告次要终点