Music for Sleep-onset Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585425
• Other study ID #: M&I2020
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: June 2, 2023

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Sleep hygiene advice
Participants receive standard sleep hygiene advice.
• Bedtime music listening
Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Sygekassernes Helsefond, University College Nordjylland, University Hospital Heidelberg, University of Oxford

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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	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.
Secondary	Sleep initiation difficulties	Difficulties initiating sleep as measured with Pittsburgh Sleep Quality Index subscale	Change from baseline to after the 4-week intervention period.
Secondary	Objective sleep quality	Objective sleep quality as measured with polysomnography	Change from baseline to after the 4-week intervention period.
Secondary	Sleep-wake pattern	Sleep-wake pattern as measured with wrist-actigraphy	Change from baseline to after the 4-week intervention period.
Secondary	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.
Secondary	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.