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

Not Applicable

Withdrawn

• Conditions: Hearing Impairment
• Interventions: Diagnostic Test: cognitive testing with HAD (PockeTalker) First; Diagnostic Test: Cognitive testing without HAD First

• Registration Number: NCT03338751
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-27
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-08
• Last Update Submitted: 2017-11-08
• Study First Posted: 2017-11-09
• Last Update Posted: 2017-11-09
• Study Start: 2018-01
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hearing Assistance Device (HAD) First	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. Participants randomized to HAD first will use a Hearing Aid Device.
No Hearing Assistance Device (HAD) First	cognitive testing with HAD (PockeTalker) First	Sham hearing aid device
Hearing Assistance Device (HAD) First	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. Participants randomized to HAD first will use a Hearing Aid Device.
No Hearing Assistance Device (HAD) First	Cognitive testing without HAD First	Sham hearing aid device

Primary Outcome Measures

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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States