Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents
NCT ID: NCT03338751
Last Updated: 2017-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-01-31
2019-01-31
Brief Summary
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Investigators are asking residents to perform cognitive tests with and without hearing assistance equipment known as PockeTalkers. This study will be conducted at one urban Skilled Nursing Facility (SNF) with the goal of understanding the extent to which hearing impairment impacts commonly used cognitive impairment measures for clinical assessment. Cognitive performance will be measured, cerumen occlusion, and perceived hearing.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Hearing Assistance Device (HAD) First
Tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second. Participants randomized to HAD first will use a Hearing Aid Device.
cognitive testing with HAD (PockeTalker) First
tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
Cognitive testing without HAD First
tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
No Hearing Assistance Device (HAD) First
Sham hearing aid device
cognitive testing with HAD (PockeTalker) First
tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
Cognitive testing without HAD First
tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
Interventions
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cognitive testing with HAD (PockeTalker) First
tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
Cognitive testing without HAD First
tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ability to communicate and follow simple commands
* capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.
Exclusion Criteria
* obtunded or comatose state
* inability to communicate verbally
* inability to consent and without surrogate
* non-English speaking
18 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Joshua Chodosh, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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17-00697
Identifier Type: -
Identifier Source: org_study_id