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Completed

NCT Number: NCT03676491

Music to Improve Sleep Quality in Adults With Depression and Insomnia

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.

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Key information

Conditions

Insomnia Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit for Depression, Psychiatry

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music intervention

Other

Music intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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)

  8. 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)

  9. 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)

Other outcomes

  1. Duration of music intervention

    Time frame: 4 week music intervention period

    log file data on duration of music intervention

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aase & Ejnar Danielsens Foundation
  • Health Research Foundation
  • The Obel Family Foundation

Registry information

Official study title

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

Acronym: MUSTAFI

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 18, 2018
Registry last updated
Dec 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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