Insomnia, Sleep Disorders
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALMusic
Participants choice among 4 genres of music matched on music characteristics
BEHAVIORALAudiobook
Participants choice among 4 types of audiobooks
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in insomnia severity | Baseline and three-weeks follow-up | Measured with the Insomnia Severity Index (ISI) |
| Change in subjective sleep quality | Baseline and three-weeks follow-up | Measured with the Pittsburgh Sleep Quality Index (PSQI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in objective sleep quality (actigraphy) | Baseline and three-weeks follow-up | Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with actigraphy |
| Change in objective sleep quality (PSG) | Baseline and three-weeks follow-up | Total sleep time, Sleep efficiency, sleep onset latency and wake after sleep onset as measured with polysomnography |
| Change in daytime dysfunction | Baseline and three-weeks follow-up | Measured with the Fatigue severity scale (FSS), Becks Depression inventory (BDI-II), State-Trait Anxiety Inventory (STAI) and WHOQOL-BREF |
| Change in physiological arousal | Baseline and three-weeks follow-up | Measured with ECG and respiration rate |
Countries
Denmark
Outcome results
None listed