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Completed

NCT Number: NCT02376686

Music Intervention in the Treatment of Sleep Disorders for Depressed Patients

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.

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Key information

Conditions

Insomnia Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanatorium Kilchberg AG

Kilchberg, Canton of Zurich, 8802, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,

Exclusion criteria

  • 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

Treatment and study plan

Music intervention

Other

Patient receives Music Intervention before going to sleep. It is composed Music which the Patient hear with maysound Music player.

Primary outcomes

  1. objective sleep Quality

    Time frame: up to four weeks

    Measurement with actimeter

Secondary outcomes

  1. subjective sleep Quality

    Time frame: up to eight weeks

    Measurement by questionnaire, Pittsburg Sleep Quality Index

Other outcomes

  1. severity of depressive symptoms

    Time frame: up to eight weeks

    Measurement by questionnaire, Beck Depression inventory

Sponsors and collaborators

Lead sponsor

Sanatorium Kilchberg AG

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2015
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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