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Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents

Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03338751
Acronym
DECIPHER
Enrollment
0
Registered
2017-11-09
Start date
2018-01-31
Completion date
2019-01-31
Last updated
2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Impairment

Brief summary

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.

Interventions

DIAGNOSTIC_TESTcognitive 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.

DIAGNOSTIC_TESTCognitive 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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* admitted to unit of intervention * 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

* not on the unit of intervention * obtunded or comatose state * inability to communicate verbally * inability to consent and without surrogate * non-English speaking

Design outcomes

Primary

MeasureTime frameDescription
Measure of Cognitive function using Mini-Cog20 Minutesthree-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.
Perceived Hearing measured by Hearing Handicap Inventory for the Elderly-Screening Version (HHIE)20 MinutesHHIE-S is a valid, robust test for identifying hearing-impaired elderly, irrespective of the audiometric definition used to finally diagnose hearing difficulties.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026