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临床试验/NCT01530451
NCT01530451终止3 期

Prospective, Randomized, Double-blind Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
9
试验地点
1
主要终点
Change in no. of nocturia

研究概览

简要总结

The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.

详细描述

Nocturia is one of the commonest urinary symptoms in elderly and in patients with obstructive sleep apnoea (OSA). According to the International Continence Society (ICS) definition, nocturia is defined as "the complaint that the individual has to wake at night one or more times to void" . It implies a continuum beginning from what might be considered normal, to a bothersome state. Bothersome nocturia is a common and age-dependent condition. A prevalence ranging from 48.6% to 77% were reported in the literature. Pathogenesis of nocturia is multi-factorial, and has closely related to OSA. OSA patients generate negative intrathoracic pressure during sleep, this leads to increased venous return and distension of the right atrium. This leads to an increase of hormone secretion, namely Atrial Natriuretic Peptide (ANP). ANP causes increased sodium and water excretion, and inhibits the secretion of antidiuretic hormone. All of the above factors results in an increased nocturnal urine production and nocturia.

Middle-aged men with OSA always present to urology clinic with lower urinary tract symptoms with predominant nocturia. Many a time they were treated as benign prostatic hyperplasia with multiple medications with suboptimal response. The underlying genuine pathology of OSA-related nocturia is overlooked.

Desmopressin is an analogue of antidiuretic hormone, it is the pharmacological therapy of choice for patients with nocturia where night-time polyuria is present.

In this study, the investigators would like to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult male or female patient (aged</=65 years old)
  • Obstructive sleep apnoea diagnosed by sleep study
  • Stable treatment on obstructive sleep apnoea and / or LUTS
  • Nocturia on average more than once per night
  • Having the ability to communicate and comply with the requirements of the study

排除标准

  • Presence of urethral strictures and neurogenic bladder dysfunction
  • Clinical evidence of bladder stones, bladder tumor or an active urinary tract infection
  • History of prostate cancer or prostate specific antigen (PSA) level > 10ng/ml or suspicious of prostate cancer on digital rectal examination (DRE), unless a transrectal biopsy of prostate has been performed and the presence of prostate cancer has been excluded.
  • Patient on intermittent self-catheterisation
  • Recent start or change of treatment on obstructive sleep apnoea and / or nocturia
  • Uncontrolled medical problems: e.g. Diabetes Mellitus or Diabetes insipidus
  • Hyponatraemia
  • Pregnancy

研究组 & 干预措施

A: Drug/ Placebo

Experimental

Initial phase on Desmopressin and then cross over to placebo on the second phase

干预措施: Desmopressin (Drug)

A: Drug/ Placebo

Experimental

Initial phase on Desmopressin and then cross over to placebo on the second phase

干预措施: Placebo (Drug)

B: Placebo/ Drug

Experimental

Initial phase on Placebo and then cross over to Desmopressin on the second phase

干预措施: Desmopressin (Drug)

B: Placebo/ Drug

Experimental

Initial phase on Placebo and then cross over to Desmopressin on the second phase

干预措施: Placebo (Drug)

结局指标

主要结局

Change in no. of nocturia

时间窗: Week 4 and Week 13

次要结局

  • Change of quality of Sleep - PSQI(Week 4 and Week 13)
  • Change in lower urinary tract symptoms - OABSS(Week 4 and Week 13)
  • Side effects related to desmopressin(up to Week 13)
  • Change in quality of Life - NQOL(Week 4 and Week 13)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eddie SY Chan, MD

Honorary Associate Professor

Chinese University of Hong Kong

研究点 (1)

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