Music for Dementia-related Sleep Problems | NCT03445299

Studies
Music for Dementia-related Sleep Problems

NCT03445299

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jan 25, 2019Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Dementia
Insomnia

Interventions

Music

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 26, 2018Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 1, 2018Actual

First Submitted Date

Dec 21, 2017

First Submission Date that Met QC Criteria

Feb 19, 2018

First Posted Date

Feb 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2019

Last Update Posted Date

Jan 25, 2019Actual

Name	Class
Technical University of Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Music	Experimental	Daily music listening for 30 minutes at bedtime	Behavioral: Music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Music	Behavioral	Listening to music for 30 minutes at bedtime	Music

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dementia
Sleep problems

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Larsen	Technical University of Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Music in the Brain		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009147	Music Therapy

Ancestor Terms

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided