Music for Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321826
• Other study ID #: M&I2015
• Status: Completed
• Phase: N/A
• First received: December 10, 2014
• Last updated: September 29, 2017
• Start date: April 2015
• Est. completion date: September 29, 2017

Study information

• Verified date: April 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 29, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insomnia
• Parasomnias
• Sleep Disorders
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Behavioral:
• Music
Participants choice among 4 genres of music matched on music characteristics
• Audiobook
Participants choice among 4 types of audiobooks

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insomnia severity	Measured with the Insomnia Severity Index (ISI)	Baseline and three-weeks follow-up
Primary	Change in subjective sleep quality	Measured with the Pittsburgh Sleep Quality Index (PSQI)	Baseline and three-weeks follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in physiological arousal	Measured with ECG and respiration rate	Baseline and three-weeks follow-up