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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02376686
Other study ID # KEK-ZH-Nr.2013-0544
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date February 2023

Study information

Verified date February 2023
Source Sanatorium Kilchberg AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Switzerland Sanatorium Kilchberg AG Kilchberg ZH

Sponsors (1)

Lead Sponsor Collaborator
Sanatorium Kilchberg AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Harmat L, Takacs J, Bodizs R. Music improves sleep quality in students. J Adv Nurs. 2008 May;62(3):327-35. doi: 10.1111/j.1365-2648.2008.04602.x. — View Citation

Jespersen KV, Vuust P. The Effect of Relaxation Music Listening on Sleep Quality in Traumatized Refugees: A Pilot Study. J Music Ther. 2012 Summer;49(2):205-29. doi: 10.1093/jmt/49.2.205. — View Citation

Jindal RD, Thase ME. Treatment of insomnia associated with clinical depression. Sleep Med Rev. 2004 Feb;8(1):19-30. doi: 10.1016/S1087-0792(03)00025-X. — View Citation

Maratos AS, Gold C, Wang X, Crawford MJ. Music therapy for depression. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004517. doi: 10.1002/14651858.CD004517.pub2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other severity of depressive symptoms Measurement by questionnaire, Beck Depression inventory up to eight weeks
Primary objective sleep Quality Measurement with actimeter up to four weeks
Secondary subjective sleep Quality Measurement by questionnaire, Pittsburg Sleep Quality Index up to eight weeks
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