Music for Dementia-related Sleep Problems

Dementia Clinical Trial

Official title:

Dementia and Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445299
• Other study ID #: D&S2017
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Dementia

• Sleep problems

Exclusion Criteria:

• Use of hypnotic medications

• Substance abuse

• Severe hearing deficits

• Not out of bed during daytime

Related Conditions & MeSH terms

• Dementia
• Insomnia

Intervention

Behavioral:
• Music
Listening to music for 30 minutes at bedtime

Locations

Country	Name	City	State
Denmark	Center for Music in the Brain	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep	Change in sleep pattern measured objectively with wrist actigraphy	14 days baseline and 14 days intervention
Secondary	Sleep quality	Change in sleep quality reported by primary caregiver (5 point Likert scale: 0=no change - 4=extreme change)	After 14 days intervention period
Secondary	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.	Measured at baseline and after 14 days intervention period
Secondary	Cognition	Change in cognitive functioning as measured by the Mini-Mental-State Examination (MMSE)	Measured at baseline and after 14 days intervention period
Secondary	Mood	Change in mood as reported by primary caregiver (5 point Likert scale: 0= no change - 4=extreme change)	After 14 days intervention period