NCT02321826

Brief Summary

The aim of this study is to determine the effect of listening to music on sleep quality (subjective and objective), daytime dysfunction and neurophysiological arousal in patients with insomnia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

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

December 10, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
Last Updated

October 3, 2017

Status Verified

April 1, 2017

Enrollment Period

2.5 years

First QC Date

December 10, 2014

Last Update Submit

September 29, 2017

Conditions

InsomniaSleep Disorders

Outcome Measures

Primary Outcomes (2)

  • Change in insomnia severity

    Measured with the Insomnia Severity Index (ISI)

    Baseline and three-weeks follow-up

  • Change in subjective sleep quality

    Measured with the Pittsburgh Sleep Quality Index (PSQI)

    Baseline and three-weeks follow-up

Secondary Outcomes (4)

  • Change in objective sleep quality (PSG)

    Baseline and three-weeks follow-up

  • Change in objective sleep quality (actigraphy)

    Baseline and three-weeks follow-up

  • Change in daytime dysfunction

    Baseline and three-weeks follow-up

  • Change in physiological arousal

    Baseline and three-weeks follow-up

Study Arms (3)

Music

EXPERIMENTAL

Listening to music for 45 minutes at bedtime

Behavioral: Music

Audiobook

ACTIVE COMPARATOR

Listening to audiobook for 45 minutes at bedtime

Behavioral: Audiobook

Control

NO INTERVENTION

No intervention control group

Interventions

MusicBEHAVIORAL

Participants choice among 4 genres of music matched on music characteristics

Music
AudiobookBEHAVIORAL

Participants choice among 4 types of audiobooks

Audiobook

Eligibility Criteria

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

You may qualify if:

  • Insomnia diagnosis

You may not qualify if:

  • Use of hypnotic medications
  • Alcohol or substance abuse
  • Pregnant or breastfeeding women
  • Sleep apnea with an apnea hypopnea index (AHI) \>15
  • Clinically significant restless leg syndrome or periodic limp movement disorder (PLMS\>25)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake Disorders

Interventions

Music TherapySound Recordings

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Kira V Jespersen

    Center of Functionally Integrative Neuroscience, Aarhus University

    PRINCIPAL INVESTIGATOR

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

December 10, 2014

First Posted

December 22, 2014

Study Start

April 1, 2015

Primary Completion

September 29, 2017

Study Completion

September 29, 2017

Last Updated

October 3, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)