Better Night - Better Day: a Randomized Controlled Trial of Listening to Music for Improving Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in insomnia severity
研究概览
简要总结
The aim of this study is to determine the effect of listening to music on sleep quality (subjective and objective), daytime dysfunction and neurophysiological arousal in patients with insomnia.
详细描述
Sleep problems are highly prevalent in modern society and poor sleep is associated with impaired physical and mental health with large costs for both individuals and society. Pharmacological treatment is recommended only for short-term use, and there is a need to study promising drug-free aids to improve sleep. Furthermore, the mechanisms of insomnia are not well understood. In the present project we will investigate if listening to music can improve sleep quality in persons suffering from insomnia. We will use a randomized controlled trial design including both subjective and objective measures of sleep.
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
- •Insomnia diagnosis
排除标准
- •Use of hypnotic medications
- •Alcohol or substance abuse
- •Pregnant or breastfeeding women
- •Sleep apnea with an apnea hypopnea index (AHI) >15
- •Clinically significant restless leg syndrome or periodic limp movement disorder (PLMS>25)
研究组 & 干预措施
Music
Listening to music for 45 minutes at bedtime
干预措施: Music (Behavioral)
Audiobook
Listening to audiobook for 45 minutes at bedtime
干预措施: Audiobook (Behavioral)
Control
No intervention control group
结局指标
主要结局
Change in insomnia severity
时间窗: Baseline and three-weeks follow-up
Measured with the Insomnia Severity Index (ISI)
Change in subjective sleep quality
时间窗: Baseline and three-weeks follow-up
Measured with the Pittsburgh Sleep Quality Index (PSQI)
次要结局
- Change in objective sleep quality (PSG)(Baseline and three-weeks follow-up)
- Change in objective sleep quality (actigraphy)(Baseline and three-weeks follow-up)
- Change in daytime dysfunction(Baseline and three-weeks follow-up)
- Change in physiological arousal(Baseline and three-weeks follow-up)