An interventional study of cognitive testing with HAD (PockeTalker) First and Cognitive testing without HAD First in Hearing Impairment, sponsored by NYU Langone Health. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-09.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Health services research
The purpose of the study is to see if a commercially available hearing assistance device called the PockeTalker has an effect on performance on cognitive (memory and thinking) tests among skilled nursing facility residents.
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.
1,109 studies on the registry are indexed under Hearing Loss; 233 are open to participants now.
Browse Hearing Loss studies →NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.
Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.
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Exclusion Criteria:
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.
Diagnostic Test: cognitive testing with HAD (PockeTalker) First · Diagnostic Test: Cognitive testing without HAD First
Sham hearing aid device
Diagnostic Test: cognitive testing with HAD (PockeTalker) First · Diagnostic Test: 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.
Also known as: PockeTalker Hearing Aid Device
tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
Measure of Cognitive function using Mini-Cog
three-item recall and a clock draw test. 24 Medical assistants have been trained and have employed this test successfully in primary care practices. The Mini-Cog has test characteristics that are comparable to any other brief instrument and exceeds most in accuracy or predictive quality.
Time frame: 20 Minutes
Perceived Hearing measured by Hearing Handicap Inventory for the Elderly-Screening Version (HHIE)
HHIE-S is a valid, robust test for identifying hearing-impaired elderly, irrespective of the audiometric definition used to finally diagnose hearing difficulties.
Time frame: 20 Minutes
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2018; primary completion for Jan 2019, 12 months later.
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This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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