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Choral Singing For the Prevention of Dementia

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ClinicalTrials.gov Identifier: NCT02919748
Recruitment Status : Unknown
Verified March 2018 by Feng Lei, National University, Singapore.
Recruitment status was:  Recruiting
First Posted : September 29, 2016
Last Update Posted : April 2, 2018
Sponsor:
Collaborators:
Agency for Science, Technology and Research
Nanyang Technological University
University of Cambridge
Ministry of Health, Singapore
Information provided by (Responsible Party):
Feng Lei, National University, Singapore

Brief Summary:
To evaluate the efficacy of choral singing in the prevention of dementia and examine the underlying mechanisms using Magnetic Resonance Imaging (MRI) technique and a panel of peripheral biomarkers in venous blood and urine. The investigators hypothesize that Choral singing could prevent cognitive decline among community-dwelling elderly who are at high risk of dementia. The underlying neural mechanisms involve the changes in brain structure and function that can be quantified using MRI technique. The changes in cognitive outcomes will be accompanied by observable changes from a panel of carefully selected peripheral biomarkers.

Condition or disease Intervention/treatment Phase
Dementia Cognitive Decline Other: Choral Singing Other: Health Education Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Choral Singing For the Prevention of Dementia: A Randomized Controlled Trial
Study Start Date : July 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Intervention arm
Choral Singing
Other: Choral Singing
Weekly sessions at 1 hour of choral singing.

Active Comparator: Control arm
General Health Education Program and Group Activities
Other: Health Education Program
Weekly session at 1 hour of health education talk and group activities




Primary Outcome Measures :
  1. Changes in cognitive performance [ Time Frame: Baseline, 1 year, 2 year ]
    Measured using a composite cognitive test score based on results from a battery of 6 cognitive tests that measures the performance on multiple cognitive domains. The composite cognitive test score (CCTS) will be calculated as the average of Z scores standardised to the baseline mean and standard deviation of trial participants, with higher scores representing better cognitive performance.


Secondary Outcome Measures :
  1. Changes in brain structure and function [ Time Frame: Baseline, 1 year, 2 year ]
    Measured using brain magnetic resonance imaging (MRI)

  2. Changes in biological markers [ Time Frame: Baseline, 1 year, 2 year ]
    Measured using biological sampling

  3. Depressive symptoms [ Time Frame: Baseline, 6 month, 1 year, 2 year ]
    Measured using the Geriatric Depression Scale (GDS-15)

  4. Anxiety symptoms [ Time Frame: Baseline, 6 month, 1 year, 2 year ]
    Measured using the Geriatric Anxiety Inventory (GAI)

  5. Stress [ Time Frame: Baseline, 6 month, 1 year, 2 year ]
    Measured using the Perceived Stress Scale (PSS)

  6. Sleep quality [ Time Frame: Baseline, 6 month, 1 year, 2 year ]
    Measured using the Pittsburgh Sleep Quality Index (PSQI)

  7. Neuropsychiatric symptoms [ Time Frame: Baseline, 6 month, 1 year, 2 year. ]
    Measured using the Neuropsychiatric Inventory (NPI)

  8. Changes in Rey Auditory Verbal Learning Test [ Time Frame: Baseline, 1 year, 2 year ]
    Measured using Rey Auditory Verbal Learning Test (RAVLT)

  9. Changes in Digit Span [ Time Frame: Baseline, 1 year, 2 year ]
    Measured using Digit Span Task

  10. Changes in Block Design [ Time Frame: Baseline, 1 year, 2 year ]
    Measured using Block Design Test

  11. Changes in Color Trails [ Time Frame: Baseline, 1 year, 2 year ]
    Measured using Color Trails tests

  12. Changes in Symbol Digit Modality [ Time Frame: Baseline, 1 year, 2 year ]
    Measured using Symbol Digit Modality Test (SDMT)

  13. Changes in Boston Naming [ Time Frame: Baseline, 1 year, 2 year ]
    Measured using Boston Naming Test

  14. Severity of symptoms of dementia [ Time Frame: Baseline, 1 year, 2 year ]
    Measured using the Clinical Dementia Rating (CDR)

  15. Changes in Mini-Mental State Examination [ Time Frame: Baseline, 6 month, 1 year, 2 year ]
    Measured using the Mini-Mental State Examination (MMSE)

  16. Changes in Montreal Cognitive Assessment [ Time Frame: Baseline, 6 month, 1 year, 2 year ]
    Measured using the Montreal Cognitive Assessment (MoCA)



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Community-living elderly aged 60 years and above, and
  2. Subjective cognitive complaints based on self-report, or
  3. Objective cognitive impairment based on neuropsychological test scores (Z score < 0 and >-1.5), or
  4. Multiple risk factors of dementia such as family history, depression, etc., and
  5. Not demented: Clinical Dementia Rating (CDR) global score=0

Exclusion Criteria:

  1. Any terminal illness, OR
  2. Stroke, OR
  3. Aphasia, OR
  4. Marked hearing impairment, OR
  5. Participating in another interventional study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919748


Contacts
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Contact: Lei Feng, Medicine 65-67723491 pcmfl@nus.edu.sg
Contact: Elisabeth Ow, Nursing 65-67910134 pcmokte@nus.edu.sg

Locations
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Singapore
TaRA@JP Recruiting
Singapore, Singapore, 648886
Contact: Elisabeth Ow, Nursing    65-67910134    pcmokte@nus.edu.sg   
Principal Investigator: Lei Feng, MD, PhD         
Sponsors and Collaborators
National University, Singapore
Agency for Science, Technology and Research
Nanyang Technological University
University of Cambridge
Ministry of Health, Singapore
Investigators
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Principal Investigator: Lei Feng, Medicine National University, Singapore
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Feng Lei, Dr, National University, Singapore
ClinicalTrials.gov Identifier: NCT02919748    
Other Study ID Numbers: NUS-IRB: B-14-304
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Feng Lei, National University, Singapore:
dementia
cognitive decline
choral singing
health education program
randomized controlled trial
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders