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Completed

NCT Number: NCT03445299

Music for Dementia-related Sleep Problems

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

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurocognitive Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Music in the Brain

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dementia
  • Sleep problems

Exclusion criteria

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

Treatment and study plan

Music

Behavioral

Listening to music for 30 minutes at bedtime

Primary outcomes

  1. Sleep

    Time frame: 14 days baseline and 14 days intervention

    Change in sleep pattern measured objectively with wrist actigraphy

Secondary outcomes

  1. 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)

  2. 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.

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Technical University of Denmark

Registry information

Official study title

Dementia and Sleep

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2018
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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