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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Participants receive standard sleep hygiene advice.
Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes.
Aarhus University Hospital
Aarhus, Denmark
Insomnia severity
Measured with the Insomnia Severity Index, range 0-28 with higher scores indicating more severe insomnia.
Time frame: Change from baseline to after the 4-week intervention period.
Sleep quality
Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems.
Time frame: Change from baseline to after the 4-week intervention period.
Sleep initiation difficulties
Difficulties initiating sleep as measured with Pittsburgh Sleep Quality Index subscale
Time frame: Change from baseline to after the 4-week intervention period.
Objective sleep quality
Objective sleep quality as measured with polysomnography
Time frame: Change from baseline to after the 4-week intervention period.
Sleep-wake pattern
Sleep-wake pattern as measured with wrist-actigraphy
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to after the 4-week intervention period.
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