Music for Sleep-onset Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Sleep hygiene advice; Behavioral: Bedtime music listening

• Registration Number: NCT04585425
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-14
• Study Start: 2021-05-01
• Primary Completion: 2023-04-10
• Study Completion: 2023-06-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Sleep-onset insomnia for 3-18 months

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Bedtime music listening	Treatment as usual (sleep hygiene advice) and bedtime music listening
Control	Sleep hygiene advice	Treatment as usual including sleep hygiene advice
Intervention	Sleep hygiene advice	Treatment as usual (sleep hygiene advice) and bedtime music listening

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark