Music to Improve Sleep Quality in Adults With Depression and Insomnia

Depression Clinical Trial

— MUSTAFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676491
• Other study ID #: N-20170055
• Secondary ID: N-20170055
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: December 23, 2020

Study information

• Verified date: December 2020
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 23, 2020
• Est. primary completion date: December 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Music Intervention
Music intervention

Locations

Country	Name	City	State
Denmark	Unit for Depression, Psychiatry	Aalborg

Sponsors (4)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aase & Ejnar Danielsens Foundation, Health Research Foundation, The Obel Family Foundation

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Fava M. Daytime sleepiness and insomnia as correlates of depression. J Clin Psychiatry. 2004;65 Suppl 16:27-32. Review. — View Citation

Jespersen KV, Koenig J, Jennum P, Vuust P. Music for insomnia in adults. Cochrane Database Syst Rev. 2015 Aug 13;(8):CD010459. doi: 10.1002/14651858.CD010459.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of music intervention	log file data on duration of music intervention	4 week music intervention period
Primary	Sleep Quality - subjective	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	Sleep Quality - subjective	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
Secondary	Sleep Quality - objective	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
Secondary	Sleep Quality - objective	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
Secondary	Symptoms of depression	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
Secondary	Symptoms of depression	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
Secondary	Quality of life measuring subjective well-being	The World Health Well-Being Index (WHO-5)	Change of quality of life from baseline at 4 weeks
Secondary	Quality of life measuring subjective well-being	The World Health Well-Being Index (WHO-5)	Change of quality of life from baseline at 8 weeks
Secondary	Quality of life measuring subjective psychological health, physical health, social relationships and environment.	The World Health Organization Quality of Life (WHOQOL-Bref)	Change of quality of life from baseline at 4 weeks
Secondary	Quality of life measuring subjective psychological health, physical health, social relationships and environment.	The World Health Organization Quality of Life (WHOQOL-Bref)	Change of quality of life from baseline at 8 weeks