InsomniaMUSTAFINCT03676491
Music to Improve Sleep Quality in Adults With Depression and Insomnia
A study testing Music Intervention in people with Insomnia and Depression, run by Aalborg University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Depression
- What is being tested?
- Music Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteDenmark
- Study dates
- 23 May 2018to 23 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- improving sleep quality,
- reducing symptoms of depression and
- 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.
Read the 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.
- Conditions
- Insomnia, Depression
- Being tested
- Music Intervention
- Keywords
- music, depression, sleep disturbances, insomnia, quality of life
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music InterventionOther
Music intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Music Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change of sleep quality from baseline at 4 weeks
Secondary outcomes (9)
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.
Measured: Change of sleep quality from baseline at 8 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change of depression level from baseline at 8 weeks
Quality of life measuring subjective well-being
The World Health Well-Being Index (WHO-5)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change of quality of life from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start23 May 2018
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Foundation, The Obel Family Foundation, Aase & Ejnar Danielsens Foundation
- Responsible party
- Principal investigator, Helle Nystrup Lund, Aalborg University Hospital
- Investigators
- Soeren Risom Kristensen, Professor, Study director, Aalborg University, Doctoral School in Medicine, biomedical science and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676491
- Sponsor's protocol ID
- N-20170055
- Other IDs
- N-20170055
- Acronym
- MUSTAFI
- Status last verified
- Dec 2020
- First submitted
- 29 Aug 2018
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fava M. Daytime sleepiness and insomnia as correlates of depression. J Clin Psychiatry. 2004;65 Suppl 16:27-32.
PubMed 15575802Jespersen 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.
PubMed 26270746Jespersen 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.
PubMed 36000763Lund 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.
PubMed 35697087Lund 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.
PubMed 32245512
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music to Improve Sleep Quality in Adults With Depression and Insomnia: a Randomized Controlled Trial Using Mixed Methods
- ClinicalTrials.gov ID
- NCT03676491
- Acronym / sponsor ID
- MUSTAFI / N-20170055
- Conditions
- Insomnia, Depression
- Keywords
- music, depression, sleep disturbances, insomnia, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Health Research Foundation, The Obel Family Foundation, Aase & Ejnar Danielsens Foundation
- Study start
- 23 May 2018 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- improving sleep quality,
- reducing symptoms of depression and
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Music InterventionMusic 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music InterventionMusic intervention | Other | Experimental Group |
Primary outcome
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
9 secondary outcomes
Sleep Quality - subjective
Time frame: Change of sleep quality from baseline at 8 weeks
Sleep Quality - objective
Time frame: Change of sleep quality from baseline at 4 weeks
Sleep Quality - objective
Time frame: Change of sleep quality from baseline at 8 weeks
Symptoms of depression
Time frame: Change of depression level from baseline at 4 weeks
Symptoms of depression
Time frame: 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
Quality of life measuring subjective well-being
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Background: PubMed 15575802Fava M. Daytime sleepiness and insomnia as correlates of depression. J Clin Psychiatry. 2004;65 Suppl 16:27-32.
- Background: PubMed 26270746Jespersen 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.
- Derived from this study: PubMed 36000763Jespersen 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.
- Derived from this study: PubMed 35697087Lund 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.
- Derived from this study: PubMed 32245512Lund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soeren Risom Kristensen, Professor study director
Aalborg University, Doctoral School in Medicine, biomedical science and technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Intervention in people with Insomnia and Depression, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality - subjective (time frame: Change of sleep quality from baseline at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03676491, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.