Better Night - Better Day: a Randomized Controlled Trial of Listening to Music for Improving Insomnia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Change in insomnia severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Music
Listening to music for 45 minutes at bedtime
Intervention: Music (Behavioral)
Audiobook
Listening to audiobook for 45 minutes at bedtime
Intervention: Audiobook (Behavioral)
Control
No intervention control group
Outcomes
Primary Outcomes
Change in insomnia severity
Time Frame: Baseline and three-weeks follow-up
Measured with the Insomnia Severity Index (ISI)
Change in subjective sleep quality
Time Frame: Baseline and three-weeks follow-up
Measured with the Pittsburgh Sleep Quality Index (PSQI)
Secondary Outcomes
- Change in physiological arousal(Baseline and three-weeks follow-up)
- Change in objective sleep quality (PSG)(Baseline and three-weeks follow-up)
- Change in objective sleep quality (actigraphy)(Baseline and three-weeks follow-up)
- Change in daytime dysfunction(Baseline and three-weeks follow-up)