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临床试验/NCT02376686
NCT02376686已完成不适用

Musik Als Nicht-pharmakologische Intervention Zur Behandlung Von Schlafstörungen Bei Patienten Mit Depressiven Erkrankungen

Sanatorium Kilchberg AG2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年4月1日最近更新:
适应症

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
objective sleep Quality

研究概览

简要总结

The purpose of this study is to determine whether music hearing in the evening before going to sleep can improve sleep quality, depressive symptoms and quality of life in patients with affective disorders.

详细描述

Disrupted sleep including Problems of initiating and maintaining sleep are most often symptoms in patients with depressive Syndromes and often persist after successful treatment of affective symptoms. Normally disrupted sleep in the context of affective disorder is treated with sleep medication, which can lead to severe and sometimes intolerable side effects.

A non-pharmacological approach for improving sleep Quality is Hearing Music before going to sleep. Classical indian Music can improve sleep Quality in depressed patients. In a danish study protocol Western Music improved sleep quality in patients with disturbed sleep and posttraumatic stress disorder.

The investigators want to use western Music to improve sleep . In a three week Intervention time, patients shall hear before going to sleep every night for one hour relaxing Music. The control group receives Treatment as usual. After the end of Intervention, every participant has the possibility to use the sleep inducing Music.

The aim of the study is to prove whether Hearing Music before going to sleep over three weeks improves subjective sleep quality, self rated depressive symptoms and Quality of life and objective Parameters such as sleep duration and sleep latency, measured by actigraphy. In a follow-up interview four weeks after the Intervention the investigators want to prove if the effects continue after end of Intervention.

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
None

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

入选标准

  • inpatient and outpatient treatment in Sanatorium Kilchberg
  • one of the following diagnoses according to ICD 10: F32, F33, F34.1, F34.21, F34.8,
  • Age between 18 and 65 years
  • completed Primary education Level
  • good command of the german language
  • able to understand Patient information,
  • given informed consent,

排除标准

  • no informed consent
  • one or more of the following diagnoses according to ICD 10: F32.3, F33.2, F31.3, F31.4, F60.31, F10, F13, F00, F01, F02, F03, G47.3, G25.8, H90, H91
  • patients with acute suicidal tendency
  • pregnant or breastfeeding women

结局指标

主要结局

objective sleep Quality

时间窗: up to four weeks

Measurement with actimeter

次要结局

  • subjective sleep Quality(up to eight weeks)

研究者

发起方
Sanatorium Kilchberg AG
申办方类型
Other
责任方
Sponsor

研究点 (2)

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