NCT03445299

Brief Summary

The study aims to evaluate the effect of listening to music at bedtime on sleep in elderly persons with dementia and sleep problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 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 21, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 26, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

December 21, 2017

Last Update Submit

January 24, 2019

Conditions

DementiaInsomnia

Outcome Measures

Primary Outcomes (1)

  • Sleep

    Change in sleep pattern measured objectively with wrist actigraphy

    14 days baseline and 14 days intervention

Secondary Outcomes (4)

  • Sleep quality

    After 14 days intervention period

  • Depression

    Measured at baseline and after 14 days intervention period

  • Cognition

    Measured at baseline and after 14 days intervention period

  • Mood

    After 14 days intervention period

Study Arms (1)

Music

EXPERIMENTAL

Daily music listening for 30 minutes at bedtime

Behavioral: Music

Interventions

MusicBEHAVIORAL

Listening to music for 30 minutes at bedtime

Music

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dementia
  • Sleep problems

You may not qualify if:

  • Use of hypnotic medications
  • Substance abuse
  • Severe hearing deficits
  • Not out of bed during daytime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Music in the Brain

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

DementiaSleep Initiation and Maintenance Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jan Larsen

    Technical University of Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Within-subject design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2017

First Posted

February 26, 2018

Study Start

February 26, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

DK(1)