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