Music to Improve Sleep Quality in Adults With Depression and Insomnia (MUSTAFI)

December 30, 2020 updated by: Helle Nystrup Lund, Aalborg University Hospital

Music to Improve Sleep Quality in Adults With Depression and Insomnia: a Randomized Controlled Trial Using Mixed Methods

Insomnia is a common sleep disorder for patients with depression. This has a major impact on the quality of life for the individual.

The aim is to investigate, whether music intervention is effective in

  1. improving sleep quality,
  2. reducing symptoms of depression and
  3. improving quality of life

Participants use a sound pillow and selected music in the The Music Star app at home as a sleep aid in 4 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Depression is a common health problem in Denmark with a prevalence for depression of 17-18%. Depression has serious personal and social consequence. Sleep disorders are common in patients with depression. Resolving sleep disturbances in depression may prevent worsening of symptoms and relapse.

Music listening is widely used as a sleep aid. A study from the Cochrane library shows consensus that music may be helpful to improve sleep quality in insomnia. It remains unclear if music listening is helpful to patients with depression as it is to a broader population.

A randomized controlled trial address the use of music as a supplementary treatment to improve sleep in depression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Unit for Depression, Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Out patients in treatment for depression in psychiatry, Unit for Depression, Aalborg University Hospital.
  • ICD-10 diagnosis of unipolar depression F32 or F33.
  • Sleeping problems identified by HAM-D by a total score of 3 on sleep items 4-6, or a single score = 2 on at least one sleep item.
  • Following treatment standards according to national guidelines.(pharmacological treatment, psychotherapy, psycho education, Electro Convulsive Therapy).
  • 4 weeks of treatment and/or in stabilized pharmacological treatment

Exclusion Criteria:

  • ICD-10 diagnosis of depression F32 or F33 and psychotic episodes
  • substance or alcohol abuse
  • sentence to treatment by law
  • restless legs syndrome
  • obstructive sleep apnoea or other organic sleep disorders
  • hearing loss
  • dislike of music

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group

Music Intervention: Participants listen to music minimum 30 minutes at bedtime for a period of 4 weeks wearing accelerometer.

Participants are monitored for a 4 week follow up period wearing accelerometer
Other: Music Intervention
Music intervention
No Intervention: Waitlist Control Group

No intervention: Participants are monitored for a period of 4 weeks wearing accelerometer.

Participants are monitored for a 4 week follow up period wearing accelerometer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep Quality - subjective
Time Frame: Change of sleep quality from baseline at 4 weeks
Questionnaire PSQI-DK on self reported sleep measuring subjective sleep quality, sleep latency, sleep duration, sleep disturbances, daytime dysfunctions and use of antidepressant agents
Change of sleep quality from baseline at 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Quality - subjective
Time Frame: Change of sleep quality from baseline at 8 weeks
Questionnaire PSQI-DK on self reported sleep measuring subjective sleep quality, sleep latency, sleep duration, sleep disturbances, daytime dysfunctions and use of antidepressant agents.
Change of sleep quality from baseline at 8 weeks
Sleep Quality - objective
Time Frame: Change of sleep quality from baseline at 4 weeks
Accelerometer Axivity Ax3 data logger carried as a hand wrist bracelet at night. A sleep analysis function by a generic algorithm provide data on sleep estimates.
Change of sleep quality from baseline at 4 weeks
Sleep Quality - objective
Time Frame: Change of sleep quality from baseline at 8 weeks
Accelerometer Axivity Ax3 data logger carried as a hand wrist bracelet at night. A sleep analysis function by a generic algorithm provide data on sleep estimates.
Change of sleep quality from baseline at 8 weeks
Symptoms of depression
Time Frame: Change of depression level from baseline at 4 weeks
The Hamilton Depression Rating Scale (HAM-D17). The scale consist of 17 items. Total score range is 0-52. Higher numbers represent more severe symptoms.
Change of depression level from baseline at 4 weeks
Symptoms of depression
Time Frame: Change of depression level from baseline at 8 weeks
The Hamilton Depression Rating Scale (HAM-D17). The scale consist of 17 items. Total score range is 0-52. Higher numbers represent more severe symptoms.
Change of depression level from baseline at 8 weeks
Quality of life measuring subjective well-being
Time Frame: Change of quality of life from baseline at 4 weeks
The World Health Well-Being Index (WHO-5)
Change of quality of life from baseline at 4 weeks
Quality of life measuring subjective well-being
Time Frame: Change of quality of life from baseline at 8 weeks
The World Health Well-Being Index (WHO-5)
Change of quality of life from baseline at 8 weeks
Quality of life measuring subjective psychological health, physical health, social relationships and environment.
Time Frame: Change of quality of life from baseline at 4 weeks
The World Health Organization Quality of Life (WHOQOL-Bref)
Change of quality of life from baseline at 4 weeks
Quality of life measuring subjective psychological health, physical health, social relationships and environment.
Time Frame: Change of quality of life from baseline at 8 weeks
The World Health Organization Quality of Life (WHOQOL-Bref)
Change of quality of life from baseline at 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of music intervention
Time Frame: 4 week music intervention period
log file data on duration of music intervention
4 week music intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Research Foundation
The Obel Family Foundation
Aase & Ejnar Danielsens Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Soeren Risom Kristensen, Professor, Aalborg University, Doctoral School in Medicine, biomedical science and technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N-20170055 (Registry Identifier: 296056)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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