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Music Intervention in the Treatment of Sleep Disorders for Depressed Patients

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ClinicalTrials.gov Identifier: NCT02376686
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Sanatorium Kilchberg AG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Depression Other: Music intervention Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Musik Als Nicht-pharmakologische Intervention Zur Behandlung Von Schlafstörungen Bei Patienten Mit Depressiven Erkrankungen
Study Start Date : April 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Music intervention
Patient receives Music Intervention before going to sleep.
Other: Music intervention
Patient receives Music Intervention before going to sleep. It is composed Music which the Patient hear with maysound Music player.

No Intervention: treatment as usual
Patient receives Treatment as usual.



Primary Outcome Measures :
  1. objective sleep Quality [ Time Frame: up to four weeks ]
    Measurement with actimeter


Secondary Outcome Measures :
  1. subjective sleep Quality [ Time Frame: up to eight weeks ]
    Measurement by questionnaire, Pittsburg Sleep Quality Index


Other Outcome Measures:
  1. severity of depressive symptoms [ Time Frame: up to eight weeks ]
    Measurement by questionnaire, Beck Depression inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376686


Contacts
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Contact: Katja Cattapan, MD 0041-44-716-4242 k.cattapan@sanatorium-kilchberg.ch

Locations
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Switzerland
Sanatorium Kilchberg AG Recruiting
Kilchberg, ZH, Switzerland, 8802
Contact: Katja Cattapan, MD    0041-44-716-4242    k.cattapan@sanatorium-kilchberg.ch   
Sub-Investigator: Annkathrin Poepel, MD         
Sub-Investigator: Ariane Orosz, PhD         
Sub-Investigator: Nadja Weir, MD         
Sponsors and Collaborators
Sanatorium Kilchberg AG
Investigators
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Principal Investigator: Katja Cattapan, MD Sanatorium Kilchberg AG
Publications:
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Responsible Party: Sanatorium Kilchberg AG
ClinicalTrials.gov Identifier: NCT02376686    
Other Study ID Numbers: KEK-ZH-Nr.2013-0544
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Partial availability is possible
Keywords provided by Sanatorium Kilchberg AG:
sleep Quality
Depression
Music
quality of life
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms