Music for Sleep-onset Insomnia

Study Overview
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Brief Summary
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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.

Official Title
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God Nat - God Dag. A Randomized Controlled Trial of Bedtime Music as Early Intervention for Sleep-onset Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Sleep hygiene advice
* Behavioral: Bedtime music listening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sleep-onset insomnia for 3-18 months Exclusion Criteria: use of medications (benzodiazepines, z-drugs, antidepressive and anti-psychotic drugs) alcohol or substance abuse pregnant or breastfeeding women other sleep disorders (e.g. sleep apnea, restless leg syndrome, etc.) current psychiatric disorder or a history of psychotic disorders somatic disorders interfering with sleep (e.g. critical illness, pain disorders, neuro-degenerative disorders) shift work.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Treatment as usual including sleep hygiene advice | Behavioral: Sleep hygiene advice<br>* Participants receive standard sleep hygiene advice.<br>|
| Experimental: Intervention<br>Treatment as usual (sleep hygiene advice) and bedtime music listening | Behavioral: Sleep hygiene advice<br>* Participants receive standard sleep hygiene advice.<br>Behavioral: Bedtime music listening<br>* Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |