Music Intervention in the Treatment of Sleep Disorders fo... | NCT02376686

Studies
Music Intervention in the Treatment of Sleep Disorders for Depressed Patients

NCT02376686

Sponsor

Sanatorium Kilchberg AG

Status

Completed

Last Update Posted

Feb 17, 2023Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Insomnia
Depression

Interventions

Music intervention

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Feb 2023Actual

Completion Date

Feb 2023Actual

First Submitted Date

Aug 26, 2014

First Submission Date that Met QC Criteria

Feb 25, 2015

First Posted Date

Mar 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2023

Last Update Posted Date

Feb 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Music intervention	Experimental	Patient receives Music Intervention before going to sleep.	Other: Music intervention
treatment as usual	No Intervention	Patient receives Treatment as usual.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Music intervention	Other	Patient receives Music Intervention before going to sleep. It is composed Music which the Patient hear with maysound Music player.	Music intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
objective sleep Quality	Measurement with actimeter	up to four weeks

Secondary Outcomes

Measure	Description	Time Frame
subjective sleep Quality	Measurement by questionnaire, Pittsburg Sleep Quality Index	up to eight weeks

Other Outcomes

Measure	Description	Time Frame
severity of depressive symptoms	Measurement by questionnaire, Beck Depression inventory	up to eight weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katja Cattapan, MD	Sanatorium Kilchberg AG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanatorium Kilchberg AG		Kilchberg	Canton of Zurich	8802	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26753218	Background	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.
18254052	Background	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.

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D003863	Depression

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases