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| ID | Type | Description | Link |
|---|---|---|---|
| N-20170055 | Registry Identifier | 296056 |
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| Name | Class |
|---|---|
| Health Research Foundation | OTHER |
| The Obel Family Foundation | UNKNOWN |
| Aase & Ejnar Danielsens Foundation | UNKNOWN |
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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
Participants use a sound pillow and selected music in the The Music Star app at home as a sleep aid in 4 weeks.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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 |
|
| Waitlist Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Intervention | Other | Music intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Sleep Quality - objective |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of music intervention | log file data on duration of music intervention | 4 week music intervention period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soeren Risom Kristensen, Professor | Aalborg University, Doctoral School in Medicine, biomedical science and technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit for Depression, Psychiatry | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15575802 | Background | Fava M. Daytime sleepiness and insomnia as correlates of depression. J Clin Psychiatry. 2004;65 Suppl 16:27-32. | |
| 26270746 | Background | Jespersen KV, Koenig J, Jennum P, Vuust P. Music for insomnia in adults. Cochrane Database Syst Rev. 2015 Aug 13;2015(8):CD010459. doi: 10.1002/14651858.CD010459.pub2. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003863 | Depression |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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The study design is an explanatory mixed methods design in two parts. The first part is a two-arm parallel group, single center randomized controlled trial (n=120). Experimental group and waitlist control group receive standard treatment according to national guidelines. The experimental group use a sound pillow and The Music Star App at bedtime as a sleep aid in 4 weeks.The second part is an interview study (n=4). Qualitative data from a semi-structured interview on the use of music and sleep are used to discuss findings from the RCT.
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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 | 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 | 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 | 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 | 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 | 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. | 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. | The World Health Organization Quality of Life (WHOQOL-Bref) | Change of quality of life from baseline at 8 weeks |
| 36000763 | Derived | Jespersen 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. |
| 35697087 | Derived | Lund HN, Pedersen IN, Heymann-Szlachcinska AM, Tuszewska M, Bizik G, Larsen JI, Drago A, Kulhay E, Larsen A, Sorensen HO, Gronbech B, Bertelsen LR, Valentin JB, Mainz J, Johnsen SP. Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): randomized controlled trial. Nord J Psychiatry. 2023 Feb;77(2):188-197. doi: 10.1080/08039488.2022.2080254. Epub 2022 Jun 13. |
| 32245512 | Derived | Lund HN, Pedersen IN, Johnsen SP, Heymann-Szlachcinska AM, Tuszewska M, Bizik G, Larsen JI, Kulhay E, Larsen A, Gronbech B, Ostermark H, Borup H, Valentin JB, Mainz J. Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): study protocol for a randomized controlled trial. Trials. 2020 Apr 3;21(1):305. doi: 10.1186/s13063-020-04247-9. |
| D001523 |
| Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |