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

Hearing Impairment Clinical Trial

— DECIPHER  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03338751
• Other study ID #: 17-00697
• Status: Withdrawn
• Phase: N/A
• First received: October 27, 2017
• Last updated: November 8, 2017
• Start date: January 2018
• Est. completion date: January 2019

Study information

• Verified date: November 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Deafness
• Hearing Impairment
• Hearing Loss

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 Minutes
Primary	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.	20 Minutes