NCT04585425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

September 29, 2020

Last Update Submit

December 19, 2023

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Sleep quality

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

  • Sleep initiation difficulties

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

  • Objective sleep quality

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

  • Sleep-wake pattern

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

  • Quality of life

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

  • +1 more secondary outcomes

Other Outcomes (2)

  • Depressive symptoms

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

  • Anxiety

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

Study Arms (2)

Control

OTHER

Treatment as usual including sleep hygiene advice

Behavioral: Sleep hygiene advice

Intervention

EXPERIMENTAL

Treatment as usual (sleep hygiene advice) and bedtime music listening

Behavioral: Sleep hygiene adviceBehavioral: Bedtime music listening

Interventions

Sleep hygiene adviceBEHAVIORAL

Participants receive standard sleep hygiene advice.

ControlIntervention
Bedtime music listeningBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sleep-onset insomnia for 3-18 months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 36000763DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Kira V Jespersen, PhD

    University of Aarhus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 14, 2020

Study Start

May 1, 2021

Primary Completion

April 10, 2023

Study Completion

June 2, 2023

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)