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Completed

NCT Number: NCT04585425

Music 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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sleep-onset insomnia for 3-18 months

Exclusion criteria

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

Treatment and study plan

Sleep hygiene advice

Behavioral

Participants receive standard sleep hygiene advice.

Bedtime music listening

Behavioral

Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes.

Primary outcomes

  1. Insomnia severity

    Time frame: 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 outcomes

  1. Sleep quality

    Time frame: 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.

  2. Sleep initiation difficulties

    Time frame: Change from baseline to after the 4-week intervention period.

    Difficulties initiating sleep as measured with Pittsburgh Sleep Quality Index subscale

  3. Objective sleep quality

    Time frame: Change from baseline to after the 4-week intervention period.

    Objective sleep quality as measured with polysomnography

  4. Sleep-wake pattern

    Time frame: Change from baseline to after the 4-week intervention period.

    Sleep-wake pattern as measured with wrist-actigraphy

  5. Quality of life

    Time frame: 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.

  6. Pre-sleep arousal

    Time frame: 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.

Other outcomes

  1. Depressive symptoms

    Time frame: Change from baseline to after the 4-week intervention period.

    Depressive symptoms as measured with Beck Depression Inventory II, range 0-63 with higher scores indicating more severe depression.

  2. Anxiety

    Time frame: Change from baseline to after the 4-week intervention period.

    Anxiety as measured with the State-Trait Anxiety Inventory, range 0-80 with higher scores indicating more anxiety.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Sygekassernes Helsefond
  • University College Nordjylland
  • University Hospital Heidelberg
  • University of Oxford

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2020
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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