Effects of CRH on the Sleep in Patients With Hypopituitarism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Sleep-EEG variables, conventionally and quantitatively analyzed
研究概览
简要总结
In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. For example, administration of corticotropin releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore, "pure" hormone effects can be investigated.
It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was therefore to study the effect of CRH on patients with hypopituitarism.
To date, there is no information on sleep of patients with hypopituitarism. Secondary objective is therefore to compare sleep of patients with hypopituitarism with sleep of age-matched healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with hypopituitarism
- •Inclusion Criteria:
- •Age 18-75 years
- •Complete insufficiency of the anterior pituitary
- •Stable hormone substitution for at least 3 months
排除标准
- •Hormone excess in the past
- •Sleep disorder, e.g. sleep apnea syndrome
- •Healthy controls
- •Inclusion Criteria:
- •Age 18-75 years
- •Exclusion Criteria:
- •Any medication during 6 week prior to study entry
- •Shift work
结局指标
主要结局
Sleep-EEG variables, conventionally and quantitatively analyzed
时间窗: within the first month
次要结局
未报告次要终点