Music for Insomnia

Study Overview
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Brief Summary
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The aim of this study is to determine the effect of listening to music on sleep quality (subjective and objective), daytime dysfunction and neurophysiological arousal in patients with insomnia.

Detailed Description
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Sleep problems are highly prevalent in modern society and poor sleep is associated with impaired physical and mental health with large costs for both individuals and society. Pharmacological treatment is recommended only for short-term use, and there is a need to study promising drug-free aids to improve sleep. Furthermore, the mechanisms of insomnia are not well understood. In the present project we will investigate if listening to music can improve sleep quality in persons suffering from insomnia. We will use a randomized controlled trial design including both subjective and objective measures of sleep.

Official Title
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Better Night - Better Day: a Randomized Controlled Trial of Listening to Music for Improving Insomnia

Conditions
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Insomnia, Sleep Disorders

Intervention / Treatment
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* Behavioral: Music
* Behavioral: Audiobook


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insomnia diagnosis Exclusion Criteria: Use of hypnotic medications Alcohol or substance abuse Pregnant or breastfeeding women Sleep apnea with an apnea hypopnea index (AHI) >15 Clinically significant restless leg syndrome or periodic limp movement disorder (PLMS>25)

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 |
| --- | --- |
| Experimental: Music<br>Listening to music for 45 minutes at bedtime | Behavioral: Music<br>* Participants choice among 4 genres of music matched on music characteristics<br>|
| Active Comparator: Audiobook<br>Listening to audiobook for 45 minutes at bedtime | Behavioral: Audiobook<br>* Participants choice among 4 types of audiobooks<br>|
| No Intervention: Control<br>No intervention control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insomnia severity | Measured with the Insomnia Severity Index (ISI) | Baseline and three-weeks follow-up | 
| Change in subjective sleep quality | Measured with the Pittsburgh Sleep Quality Index (PSQI) | Baseline and three-weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objective sleep quality (PSG) | Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with polysomnography | Baseline and three-weeks follow-up | 
| Change in objective sleep quality (actigraphy) | Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with actigraphy | Baseline and three-weeks follow-up | 
| Change in daytime dysfunction | Measured with the Fatigue severity scale (FSS), Becks Depression inventory (BDI-II), State-Trait Anxiety Inventory (STAI) and WHOQOL-BREF | Baseline and three-weeks follow-up | 
| Change in physiological arousal | Measured with ECG and respiration rate | Baseline and three-weeks follow-up |