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Music for Dementia-related Sleep Problems

Primary Purpose

Dementia, Insomnia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Music
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Dementia
  • Sleep problems

Exclusion Criteria:

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

Sites / Locations

  • Center for Music in the Brain

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Music

Arm Description

Daily music listening for 30 minutes at bedtime

Outcomes

Primary Outcome Measures

Sleep
Change in sleep pattern measured objectively with wrist actigraphy

Secondary Outcome Measures

Sleep quality
Change in sleep quality reported by primary caregiver (5 point Likert scale: 0=no change - 4=extreme change)
Depression
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.
Cognition
Change in cognitive functioning as measured by the Mini-Mental-State Examination (MMSE)
Mood
Change in mood as reported by primary caregiver (5 point Likert scale: 0= no change - 4=extreme change)

Full Information

First Posted
December 21, 2017
Last Updated
January 24, 2019
Sponsor
University of Aarhus
Collaborators
Technical University of Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03445299
Brief Title
Music for Dementia-related Sleep Problems
Official Title
Dementia and Sleep
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Technical University of Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Within-subject design
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music
Arm Type
Experimental
Arm Description
Daily music listening for 30 minutes at bedtime
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
Listening to music for 30 minutes at bedtime
Primary Outcome Measure Information:
Title
Sleep
Description
Change in sleep pattern measured objectively with wrist actigraphy
Time Frame
14 days baseline and 14 days intervention
Secondary Outcome Measure Information:
Title
Sleep quality
Description
Change in sleep quality reported by primary caregiver (5 point Likert scale: 0=no change - 4=extreme change)
Time Frame
After 14 days intervention period
Title
Depression
Description
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.
Time Frame
Measured at baseline and after 14 days intervention period
Title
Cognition
Description
Change in cognitive functioning as measured by the Mini-Mental-State Examination (MMSE)
Time Frame
Measured at baseline and after 14 days intervention period
Title
Mood
Description
Change in mood as reported by primary caregiver (5 point Likert scale: 0= no change - 4=extreme change)
Time Frame
After 14 days intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dementia Sleep problems Exclusion Criteria: Use of hypnotic medications Substance abuse Severe hearing deficits Not out of bed during daytime
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Larsen
Organizational Affiliation
Technical University of Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Music in the Brain
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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