NCT02376686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

8.8 years

First QC Date

August 26, 2014

Last Update Submit

February 15, 2023

Conditions

InsomniaDepression

Keywords

sleep QualityDepressionMusicquality of life

Outcome Measures

Primary Outcomes (1)

  • objective sleep Quality

    Measurement with actimeter

    up to four weeks

Secondary Outcomes (1)

  • subjective sleep Quality

    up to eight weeks

Other Outcomes (1)

  • severity of depressive symptoms

    up to eight weeks

Study Arms (2)

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

Music interventionOTHER

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

Music intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanatorium Kilchberg AG

Kilchberg, Canton of Zurich, 8802, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 26753218BACKGROUND

  • 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.

    PMID: 18254052BACKGROUND

  • 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.

    PMID: 15062208BACKGROUND

  • 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.

    PMID: 18426457BACKGROUND

  • 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.

    PMID: 36000763DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepression

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Katja Cattapan, MD

    Sanatorium Kilchberg AG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

March 3, 2015

Study Start

April 1, 2014

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

CH(1)