Music for Insomnia

Not Applicable

Completed

• Conditions: Sleep Disorders; Insomnia
• Interventions: Behavioral: Music; Behavioral: Audiobook

• Registration Number: NCT02321826
• Lead Sponsor: University of Aarhus

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 Timeline

• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-22
• Study Start: 2015-04
• Status Verified: 2017-04
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Insomnia diagnosis

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music	Music	Listening to music for 45 minutes at bedtime
Audiobook	Audiobook	Listening to audiobook for 45 minutes at bedtime

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark