Music Intervention in the Treatment of Sleep Disorders for Depressed Patients
Primary Purpose
Insomnia, Depression
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Music intervention
Sponsored by

About this trial
This is an interventional treatment trial for Insomnia focused on measuring sleep Quality, Depression, Music, quality of life
Eligibility 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
Sites / Locations
- Sanatorium Kilchberg AG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music intervention
treatment as usual
Arm Description
Patient receives Music Intervention before going to sleep.
Patient receives Treatment as usual.
Outcomes
Primary Outcome Measures
objective sleep Quality
Measurement with actimeter
Secondary Outcome Measures
subjective sleep Quality
Measurement by questionnaire, Pittsburg Sleep Quality Index
Full Information
NCT ID
NCT02376686
First Posted
August 26, 2014
Last Updated
February 15, 2023
Sponsor
Sanatorium Kilchberg AG
1. Study Identification
Unique Protocol Identification Number
NCT02376686
Brief Title
Music Intervention in the Treatment of Sleep Disorders for Depressed Patients
Official Title
Musik Als Nicht-pharmakologische Intervention Zur Behandlung Von Schlafstörungen Bei Patienten Mit Depressiven Erkrankungen
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2023 (Actual)
Study Completion Date
February 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanatorium Kilchberg AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Depression
Keywords
sleep Quality, Depression, Music, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music intervention
Arm Type
Experimental
Arm Description
Patient receives Music Intervention before going to sleep.
Arm Title
treatment as usual
Arm Type
No Intervention
Arm Description
Patient receives Treatment as usual.
Intervention Type
Other
Intervention Name(s)
Music intervention
Intervention Description
Patient receives Music Intervention before going to sleep. It is composed Music which the Patient hear with maysound Music player.
Primary Outcome Measure Information:
Title
objective sleep Quality
Description
Measurement with actimeter
Time Frame
up to four weeks
Secondary Outcome Measure Information:
Title
subjective sleep Quality
Description
Measurement by questionnaire, Pittsburg Sleep Quality Index
Time Frame
up to eight weeks
Other Pre-specified Outcome Measures:
Title
severity of depressive symptoms
Description
Measurement by questionnaire, Beck Depression inventory
Time Frame
up to eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katja Cattapan, MD
Organizational Affiliation
Sanatorium Kilchberg AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanatorium Kilchberg AG
City
Kilchberg
State/Province
ZH
ZIP/Postal Code
8802
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Partial availability is possible
Citations:
PubMed Identifier
26753218
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.
Results Reference
background
PubMed Identifier
18254052
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.
Results Reference
background
PubMed Identifier
15062208
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.
Results Reference
background
PubMed Identifier
18426457
Citation
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.
Results Reference
background
PubMed Identifier
36000763
Citation
Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022 Aug 24;8(8):CD010459. doi: 10.1002/14651858.CD010459.pub3.
Results Reference
derived
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Music Intervention in the Treatment of Sleep Disorders for Depressed Patients
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