Clinical trial NCT04585425: Music for Sleep-onset Insomnia
Official title: God Nat - God Dag. A Randomized Controlled Trial of Bedtime Music as Early Intervention for Sleep-onset Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University Hospital Heidelberg
name: University College Nordjylland
name: University of Oxford
name: Sygekassernes Helsefond
First posted: 2020-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia severity
timeFrame: Change from baseline to after the 4-week intervention period.
Secondary outcomes:
measure: Sleep quality
timeFrame: Change from baseline to after the 4-week intervention period.
measure: Sleep initiation difficulties
timeFrame: Change from baseline to after the 4-week intervention period.
measure: Objective sleep quality
timeFrame: Change from baseline to after the 4-week intervention period.
measure: Sleep-wake pattern
timeFrame: Change from baseline to after the 4-week intervention period.
measure: Quality of life
timeFrame: Change from baseline to after the 4-week intervention period.
measure: Pre-sleep arousal
timeFrame: Change from baseline to after the 4-week intervention period.
Other outcomes:
measure: Depressive symptoms
timeFrame: Change from baseline to after the 4-week intervention period.
measure: Anxiety
timeFrame: Change from baseline to after the 4-week intervention period.
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: Kira V Jespersen, PhD
role: STUDY_DIRECTOR
References:
citation: 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.