跳至主要内容
临床试验/NCT01645475
NCT01645475已完成4 期

Desmopressin Melt: Impact on Sleep and Daytime Functioning? A Prospective Study.

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
IQ (Intelligent Quotient)

研究概览

简要总结

Nocturnal enuresis affects 10% of the 7-year-old children and is essentially caused by a mismatch between nocturnal bladder capacity and the amount of urine produced during the night together with failure of the child to awaken in response to a full bladder.Urine overproduction at night or nocturnal polyuria (NP) is a major factor contributing to monosymptomatic nocturnal enuresis (MNE) pathophysiology in a large proportion of patients.

Since NP is related to an abnormal circadian rhythm of arginine vasopressin (AVP) secretion, the synthetic AVP analogue desmopressin is widely used to treat MNE.

It is recommended by the International Consultation on Incontinence (grade A,level 1). Desmopressin is available in 3 different formulations: nasal spray, tablet and the newest form melt.

Baeyens et al demonstrated an increased prevalence of attention deficit-hyperactivity disorder (ADHD) in children with MNE According to recent data there is a high incidence of periodic limb movements in sleep at night in children with nocturnal enuresis. Those children have an increased cortical arousability leading to awakening.

The frequent awakening most likely has an influence on concentration and other ADHD-symptoms in daily life.

This study will assess the impact of desmopressin melt on prepulse inhibition, ADHD-symptoms, cognition and learning, sleep, quality of life and self esteem.

New patients aged 6-16 years with monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems are tested before the start of the study medication desmopressin melt (T1) and 6 months later (T2). It is a multi-method, multi-informant study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • New patient
  • age 6 to 16 years
  • monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems

排除标准

  • mental retardation
  • autism spectrum disorders
  • daytime incontinence resistant to therapy
  • dysfunctional voiding
  • poor therapy-compliance
  • diuretics, antihypertensives, uropathy, renal abnormalities

研究组 & 干预措施

Desmopressin lyophilisate (Melt)

Experimental

Patients receiving Desmopressin lyophilisate (Melt).

干预措施: Desmopressin lyophilisate (Melt) (Drug)

结局指标

主要结局

IQ (Intelligent Quotient)

时间窗: Change between day 1 before start of studymedication and 6 months later

Wechsler Intelligence Scale for Children-Third Edition (WISC-III) short version

Psychological functioning questionnaire

时间窗: Change between day 1 before start of studymedication and 6 months later

School results: copy of schoolreport (+median) (teacher)

Sleep

时间窗: Change between day 1 before start of studymedication and 6 months later

Polysomnography (overnight hospitalization) (child)

Bladder information: voiding calender

时间窗: Change between day 1 before start of studymedication and 6 months later

Voiding calendar

Urine concentration

时间窗: Change between day 1 before start of studymedication and 6 months later

Forced diuresis and 24h concentration profile with measurement of Na, K, creatinin, osmolality

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验