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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03676491
Other study ID # N-20170055
Secondary ID N-20170055
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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