Music for Insomnia

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep Disorders
• Intervention / Treatment: Behavioral: Music; Behavioral: Audiobook

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention control group
Experimental: Music; Listening to music for 45 minutes at bedtime	Behavioral: Music; Participants choice among 4 genres of music matched on music characteristics
Active Comparator: Audiobook; Listening to audiobook for 45 minutes at bedtime	Behavioral: Audiobook; Participants choice among 4 types of audiobooks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Kira V Jespersen, Center of Functionally Integrative Neuroscience, Aarhus University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 29, 2017
• Study Completion (Actual): September 29, 2017

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: M&I2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No