Music for Sleep-onset Insomnia

NCT ID: NCT04585425

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Treatment as usual including sleep hygiene advice

Group Type OTHER

Sleep hygiene advice

Intervention Type BEHAVIORAL

Participants receive standard sleep hygiene advice.

Intervention

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

Group Type EXPERIMENTAL

Sleep hygiene advice

Intervention Type BEHAVIORAL

Participants receive standard sleep hygiene advice.

Bedtime music listening

Intervention Type BEHAVIORAL

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

Interventions

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Sleep hygiene advice

Participants receive standard sleep hygiene advice.

Intervention Type BEHAVIORAL

Bedtime music listening

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role collaborator

University College Nordjylland

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

Sygekassernes Helsefond

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kira V Jespersen, PhD

Role: STUDY_DIRECTOR

University of Aarhus

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 36000763 (View on PubMed)

Other Identifiers

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M&I2020

Identifier Type: -

Identifier Source: org_study_id