Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital Heidelberg | OTHER |
| University College Nordjylland | UNKNOWN |
| University of Oxford | OTHER |
| Sygekassernes Helsefond |
Not provided
Not provided
Not provided
Not provided
Not provided
The study is a randomized controlled trial evaluating the effect of bedtime music as an early intervention for sleep-onset insomnia in adults. The investigators use a randomized controlled trial design with two parallel groups. All participants receive sleep hygiene advice as standard treatment and participants in the intervention group are additionally asked to listen to a sleep playlist daily at bedtime. Subjective and objective sleep measures are evaluated before and after the 4 weeks intervention period. In addition, follow-up measures of subjective outcomes are assessed 4 weeks after the end of the intervention period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Treatment as usual including sleep hygiene advice |
|
| Intervention | Experimental | Treatment as usual (sleep hygiene advice) and bedtime music listening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep hygiene advice | Behavioral | Participants receive standard sleep hygiene advice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia severity | Measured with the Insomnia Severity Index, range 0-28 with higher scores indicating more severe insomnia. | Change from baseline to after the 4-week intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems. | Change from baseline to after the 4-week intervention period. |
| Sleep initiation difficulties |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms | Depressive symptoms as measured with Beck Depression Inventory II, range 0-63 with higher scores indicating more severe depression. | Change from baseline to after the 4-week intervention period. |
| Anxiety |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kira V Jespersen, PhD | University of Aarhus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Bedtime music listening | Behavioral | Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes. |
|
Difficulties initiating sleep as measured with Pittsburgh Sleep Quality Index subscale
| Change from baseline to after the 4-week intervention period. |
| Objective sleep quality | Objective sleep quality as measured with polysomnography | Change from baseline to after the 4-week intervention period. |
| Sleep-wake pattern | Sleep-wake pattern as measured with wrist-actigraphy | Change from baseline to after the 4-week intervention period. |
| Quality of life | Quality of life as measured with SF-36, range 0-100 with higher scores indicating better quality of life. | Change from baseline to after the 4-week intervention period. |
| Pre-sleep arousal | Pre-sleep arousal as measured with the Pre-Sleep Arousal Scale, range 8-40 with higher scores indicating higher pre-sleep arousal. | Change from baseline to after the 4-week intervention period. |
Anxiety as measured with the State-Trait Anxiety Inventory, range 0-80 with higher scores indicating more anxiety.
| Change from baseline to after the 4-week intervention period. |
| D001523 |
| Mental Disorders |