Music for Dementia-related Sleep Problems

January 24, 2019 updated by: University of Aarhus

Dementia and Sleep

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a clinical trial to assess the effect of music listening as intervention for improving sleep in elderly persons with dementia and sleep problems. We use a within-subject design to evaluate the effect of the music intervention. Participants are persons above the age of 60 diagnosed with dementia and suffering from sleep problems. We will examine the effect of the intervention on sleep, mood and cognition.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Center for Music in the Brain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dementia
  • Sleep problems

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music
Daily music listening for 30 minutes at bedtime
Behavioral: Music
Listening to music for 30 minutes at bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep
Time Frame: 14 days baseline and 14 days intervention
Change in sleep pattern measured objectively with wrist actigraphy
14 days baseline and 14 days intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality
Time Frame: After 14 days intervention period
Change in sleep quality reported by primary caregiver (5 point Likert scale: 0=no change - 4=extreme change)
After 14 days intervention period
Depression
Time Frame: Measured at baseline and after 14 days intervention period
Change in depressive symptoms as measured by the Geriatric Depression Scale (GDS). Scoring range 0-15. 0-4=no depression, 5-7=potential depression, >8=probable depression.
Measured at baseline and after 14 days intervention period
Cognition
Time Frame: Measured at baseline and after 14 days intervention period
Change in cognitive functioning as measured by the Mini-Mental-State Examination (MMSE)
Measured at baseline and after 14 days intervention period
Mood
Time Frame: After 14 days intervention period
Change in mood as reported by primary caregiver (5 point Likert scale: 0= no change - 4=extreme change)
After 14 days intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Technical University of Denmark

Investigators

  • Study Chair: Jan Larsen, Technical University of Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2018

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

February 19, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D&S2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insomnia

Clinical Trials on Music

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe