Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03528486
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2018-03-13
Brief Title:
Interventions to Attenuate Cognitive Decline Keys to Staying Sharp
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
Interventions to Attenuate Cognitive Decline
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Different cognitive intervention approaches have been developed to attenuate decline eg cognitive engagement training or stimulation but it is not clear which approaches are efficacious It is also not clear when along the continuum of normal cognitive aging to mild cognitive impairment MCI-a transitional stage before dementia onset it is most efficacious to intervene This randomized clinical trial will determine the efficacy of a novel cognitive engagement intervention approach music training as compared to cognitive stimulation which will serve as a stringent active control Grounded in theory the central hypothesis is that interventions enhancing central auditory processing CAP a strong longitudinal predictor of MCI and dementia will improve cognition Music training is increasingly recognized as a feasible means to attenuate age-related cognitive decline Prior research and preliminary data suggest that intense piano training enhances CAP and is likely more effective than cognitive stimulation Correlational studies indicate superior CAP executive function and other cognitive abilities for adults with formal music training compared to non-musicians The specific aims of the study are to examine the efficacy of music training relative to cognitive stimulation active controls to improve CAP cognition and everyday function among older adults with and without MCI The efficacy of music training will be established and moderating effects of MCI status will be examined The proposed study further aims to elucidate the underlying mechanisms of effective cognitive intervention approaches by exploring mediators of training gains The proposed study is the first phase II randomized trial of music training to enhance older adults cognition Mediation analyses will elucidate the underlying mechanisms of intervention effects
Detailed Description:
Interventions to Attenuate Cognitive Decline Keys to Staying Sharp
The primary objectives is to examine the efficacy of music training to improve central auditory processing CAP cognition and everyday function among older adults
The secondary objectives are
To examine the moderating effects of mild cognitive impairment MCI on music training efficacy
To explore mediators of intervention effects
Design The design is a two arm randomized clinical trial examining the efficacy of music training to improve CAP cognition and everyday function in older adults with and without MCI across two time points baseline and immediate post-test
Outcomes The effects of of music training on CAP cognition and everyday functional performance will be quantified
CAP processing measures will include Time Compressed Speech 65 Words-in-Noise Dichotic Digits Test Dichotic Sentence Identification and Adaptive Tests of Temporal Resolution A composite will be derived from principal components analyses
Cognition measures will include Verbal Fluency Test phonemic fluency category fluency and category switching Trail Making Test and Digit Coding A composite will be derived from principal component analyses
Everyday Function measures will include Timed Instrumental Activities of Daily Living and Test of Everyday Attention A composite will be derived from principal component analyses
Interventions and Duration Two types of music training will be investigated The two training conditions will be equivalent in terms of frequency and duration of each session 90 minday two dayswk 10 weeks and social contact led by trainer and conducted in groups of up to 10 persons
Sample Size and Population In-person screening of a maximum of 500 potential study participants are planned to enroll up to 400 participants The goal is to have at least 200 participants complete the study Individuals with normal cognition and those with a clinical diagnosis of MCI will be included in the study
The primary objectives is to examine the efficacy of music training to improve central auditory processing CAP cognition and everyday function among older adults
The secondary objectives are
To examine the moderating effects of mild cognitive impairment MCI on music training efficacy
To explore mediators of intervention effects
Design The design is a two arm randomized clinical trial examining the efficacy of music training to improve CAP cognition and everyday function in older adults with and without MCI across two time points baseline and immediate post-test
Outcomes The effects of of music training on CAP cognition and everyday functional performance will be quantified
CAP processing measures will include Time Compressed Speech 65 Words-in-Noise Dichotic Digits Test Dichotic Sentence Identification and Adaptive Tests of Temporal Resolution A composite will be derived from principal components analyses
Cognition measures will include Verbal Fluency Test phonemic fluency category fluency and category switching Trail Making Test and Digit Coding A composite will be derived from principal component analyses
Everyday Function measures will include Timed Instrumental Activities of Daily Living and Test of Everyday Attention A composite will be derived from principal component analyses
Interventions and Duration Two types of music training will be investigated The two training conditions will be equivalent in terms of frequency and duration of each session 90 minday two dayswk 10 weeks and social contact led by trainer and conducted in groups of up to 10 persons
Sample Size and Population In-person screening of a maximum of 500 potential study participants are planned to enroll up to 400 participants The goal is to have at least 200 participants complete the study Individuals with normal cognition and those with a clinical diagnosis of MCI will be included in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None