InsomniaNCT02376686
Music Intervention in the Treatment of Sleep Disorders for Depressed Patients
A study testing Music intervention in people with Insomnia and Depression, run by Sanatorium Kilchberg AG at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Depression
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Sanatorium Kilchberg AG
Kilchberg, Canton of Zurich, 8802
About this study
Official title: Musik Als Nicht-pharmakologische Intervention Zur Behandlung Von Schlafstörungen Bei Patienten Mit Depressiven Erkrankungen
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.
Read the 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.
- Conditions
- Insomnia, Depression
- Being tested
- Music intervention
- Keywords
- sleep Quality, Depression, Music, quality of life
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
Patient receives Music Intervention before going to sleep. It is composed Music which the Patient hear with maysound Music player.
| Study group | Role | What they receive |
|---|---|---|
| Music intervention | Experimental | Patient receives Music Intervention before going to sleep. Receives: Other: Music intervention |
| treatment as usual | No intervention | Patient receives Treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective sleep Quality
Measurement with actimeter
Measured: up to four weeks
Secondary outcomes (1)
subjective sleep Quality
Measurement by questionnaire, Pittsburg Sleep Quality Index
Measured: up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startApr 2014
- Primary completionFeb 2023
- Study completionFeb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanatorium Kilchberg AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katja Cattapan, MD, Principal investigator, Sanatorium Kilchberg AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376686
- Sponsor's protocol ID
- KEK-ZH-Nr.2013-0544
- Status last verified
- Feb 2023
- First submitted
- 26 Aug 2014
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Partial availability is possible
Publications
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.
PubMed 26753218Maratos 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.
PubMed 18254052Jindal 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.
PubMed 15062208Harmat 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.
PubMed 18426457Jespersen 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.
PubMed 36000763
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musik Als Nicht-pharmakologische Intervention Zur Behandlung Von Schlafstörungen Bei Patienten Mit Depressiven Erkrankungen
- ClinicalTrials.gov ID
- NCT02376686
- Acronym / sponsor ID
- KEK-ZH-Nr.2013-0544
- Conditions
- Insomnia, Depression
- Keywords
- sleep Quality, Depression, Music, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sanatorium Kilchberg AGUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2023 (actual)
- Study completion
- Feb 2023 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music intervention | Experimental | Other: Music interventionPatient receives Music Intervention before going to sleep. |
| treatment as usual | No intervention | –Patient receives Treatment as usual. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionPatient receives Music Intervention before going to sleep. It is composed Music which the Patient hear with maysound Music player. | Other | Music intervention |
Primary outcome
objective sleep Quality
Time frame: up to four weeks
Measurement with actimeter
1 secondary outcome
subjective sleep Quality
Time frame: up to eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Background: PubMed 26753218Jespersen 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.
- Background: PubMed 18254052Maratos 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.
- Background: PubMed 15062208Jindal 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.
- Background: PubMed 18426457Harmat 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.
- Derived from this study: PubMed 36000763Jespersen 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.
- Individual participant dataSharing planned: Undecided. Partial availability is possible
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Cattapan, MD principal investigator
Sanatorium Kilchberg AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Insomnia and Depression, run by Sanatorium Kilchberg AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective sleep Quality (time frame: up to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02376686, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.