God Nat - God Dag. A Randomized Controlled Trial of Bedtime Music as Early Intervention for Sleep-onset Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Insomnia severity
研究概览
简要总结
The study is a randomized controlled trial evaluating the effect of bedtime music as an early intervention for sleep-onset insomnia in adults. The investigators use a randomized controlled trial design with two parallel groups. All participants receive sleep hygiene advice as standard treatment and participants in the intervention group are additionally asked to listen to a sleep playlist daily at bedtime. Subjective and objective sleep measures are evaluated before and after the 4 weeks intervention period. In addition, follow-up measures of subjective outcomes are assessed 4 weeks after the end of the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- 否
入选标准
- •Sleep-onset insomnia for 3-18 months
排除标准
- •use of medications (benzodiazepines, z-drugs, antidepressive and anti-psychotic drugs)
- •alcohol or substance abuse
- •pregnant or breastfeeding women
- •other sleep disorders (e.g. sleep apnea, restless leg syndrome, etc.)
- •current psychiatric disorder or a history of psychotic disorders
- •somatic disorders interfering with sleep (e.g. critical illness, pain disorders, neuro-degenerative disorders)
- •shift work.
结局指标
主要结局
Insomnia severity
时间窗: Change from baseline to after the 4-week intervention period.
Measured with the Insomnia Severity Index, range 0-28 with higher scores indicating more severe insomnia.
次要结局
- Objective sleep quality(Change from baseline to after the 4-week intervention period.)
- Sleep-wake pattern(Change from baseline to after the 4-week intervention period.)
- Sleep quality(Change from baseline to after the 4-week intervention period.)
- Quality of life(Change from baseline to after the 4-week intervention period.)
- Sleep initiation difficulties(Change from baseline to after the 4-week intervention period.)
- Pre-sleep arousal(Change from baseline to after the 4-week intervention period.)