Music for Sleep-onset Insomnia

God Nat - God Dag. A Randomized Controlled Trial of Bedtime Music as Early Intervention for Sleep-onset Insomnia

The study is a randomized controlled trial evaluating the effect of bedtime music as an early intervention for sleep-onset insomnia in adults. The investigators use a randomized controlled trial design with two parallel groups. All participants receive sleep hygiene advice as standard treatment and participants in the intervention group are additionally asked to listen to a sleep playlist daily at bedtime. Subjective and objective sleep measures are evaluated before and after the 4 weeks intervention period. In addition, follow-up measures of subjective outcomes are assessed 4 weeks after the end of the intervention period.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Sleep hygiene advice; Behavioral: Bedtime music listening

• Study Type: Interventional
• Enrollment (Actual): 60
• 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

Description

Inclusion Criteria:

• Sleep-onset insomnia for 3-18 months

Exclusion Criteria:

1. use of medications (benzodiazepines, z-drugs, antidepressive and anti-psychotic drugs)
2. alcohol or substance abuse
3. pregnant or breastfeeding women
4. other sleep disorders (e.g. sleep apnea, restless leg syndrome, etc.)
5. current psychiatric disorder or a history of psychotic disorders
6. somatic disorders interfering with sleep (e.g. critical illness, pain disorders, neuro-degenerative disorders)
7. shift work.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Treatment as usual including sleep hygiene advice	Behavioral: Sleep hygiene advice; Participants receive standard sleep hygiene advice.
Experimental: Intervention; Treatment as usual (sleep hygiene advice) and bedtime music listening	Behavioral: Sleep hygiene advice; Participants receive standard sleep hygiene advice.; Behavioral: Bedtime music listening; Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia severity	Measured with the Insomnia Severity Index, range 0-28 with higher scores indicating more severe insomnia.	Change from baseline to after the 4-week intervention period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems.	Change from baseline to after the 4-week intervention period.
Sleep initiation difficulties	Difficulties initiating sleep as measured with Pittsburgh Sleep Quality Index subscale	Change from baseline to after the 4-week intervention period.
Objective sleep quality	Objective sleep quality as measured with polysomnography	Change from baseline to after the 4-week intervention period.
Sleep-wake pattern	Sleep-wake pattern as measured with wrist-actigraphy	Change from baseline to after the 4-week intervention period.
Quality of life	Quality of life as measured with SF-36, range 0-100 with higher scores indicating better quality of life.	Change from baseline to after the 4-week intervention period.
Pre-sleep arousal	Pre-sleep arousal as measured with the Pre-Sleep Arousal Scale, range 8-40 with higher scores indicating higher pre-sleep arousal.	Change from baseline to after the 4-week intervention period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Depressive symptoms as measured with Beck Depression Inventory II, range 0-63 with higher scores indicating more severe depression.	Change from baseline to after the 4-week intervention period.
Anxiety	Anxiety as measured with the State-Trait Anxiety Inventory, range 0-80 with higher scores indicating more anxiety.	Change from baseline to after the 4-week intervention period.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: University of Oxford; University Hospital Heidelberg; Sygekassernes Helsefond; University College Nordjylland
• Investigators: Study Director: Kira V Jespersen, PhD, University of Aarhus

Publications and helpful links

General Publications

• Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022 Aug 24;8(8):CD010459. doi: 10.1002/14651858.CD010459.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: M&I2020

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No