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

NYU Langone Health

Status

Withdrawn

Conditions

Hearing Impairment

Treatments

Diagnostic Test: cognitive testing with HAD (PockeTalker) First

Diagnostic Test: Cognitive testing without HAD First

Study type

Interventional

Funder types

Other

Identifiers

NCT03338751

17-00697

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Hearing Assistance Device (HAD) First

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Cognitive testing without HAD First

Diagnostic Test: cognitive testing with HAD (PockeTalker) First

No Hearing Assistance Device (HAD) First

Active Comparator group

Description:

Sham hearing aid device

Treatment:

Diagnostic Test: Cognitive testing without HAD First

Diagnostic Test: cognitive testing with HAD (PockeTalker) First