NCT01091987已完成不适用
Pilot Study on the Feasibility of Non-pharmacological Treatment of Insomnia in Nursing Homes.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The proportion of eligible residents who accepted to participate in the non-pharmacological program and the proportion of eligible residents who completed the non-pharmacological program.
研究概览
简要总结
The study wants to examine the feasibility of a non-pharmacological approach for insomnia in nursing homes provided by trained nurses/paramedics and physicians.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female nursing home residents of age 55+ with insomnia, defined as difficulty in getting to sleep, difficulty in staying asleep, early wakening, or non-restorative sleep
排除标准
- •insufficient cognitive ability for self-reflection
- •insomnia caused by a medical disorder (hyperthyroidism, congestive heart failure, peripheral arterial disease, GORD, COPD/asthma, angina pectoris, benign prostatic hyperplasia, arthritis, other
- •insomnia caused by medication
- •substance misuse
- •other sleep disorder: restless legs syndrome, periodic limb movement disorder, sleep apnoea, narcolepsy
- •psychiatric disorder: psychotic or bipolar disorder in anamnesis, major depression present or more than 2 episodes in anamnesis
- •short stay
研究组 & 干预措施
Non-pharmacological approach of insomnia
Experimental
Non-pharmacological approach of insomnia based on cognitive-behavioural techniques (education on sleep, sleep hygiene, stimulus control, cognitive techniques)
干预措施: Non-pharmacological approach of insomnia (Behavioral)
结局指标
主要结局
The proportion of eligible residents who accepted to participate in the non-pharmacological program and the proportion of eligible residents who completed the non-pharmacological program.
时间窗: after 3 months
Evaluation takes place at the moment the program is ended according to the trained caregiver or maximally 3 months after the start of the program.
次要结局
- Insomnia, as measured by the Groningen Sleep Quality Questionnaire(at baseline and after 3 months)
- quality of life(at baseline and after 3 months)
- Use of sleep medication(at baseline and after 3 months)
研究者
研究点 (1)
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