NCT03338751

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

October 27, 2017

Last Update Submit

November 8, 2017

Conditions

Hearing Impairment

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Hearing Assistance Device (HAD) First

ACTIVE COMPARATOR

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) FirstDiagnostic Test: Cognitive testing without HAD First

No Hearing Assistance Device (HAD) First

ACTIVE COMPARATOR

Sham hearing aid device

Diagnostic Test: cognitive testing with HAD (PockeTalker) FirstDiagnostic Test: Cognitive testing without HAD First

Interventions

cognitive testing with HAD (PockeTalker) FirstDIAGNOSTIC_TEST

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
Hearing Assistance Device (HAD) FirstNo Hearing Assistance Device (HAD) First
Cognitive testing without HAD FirstDIAGNOSTIC_TEST

tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.

Hearing Assistance Device (HAD) FirstNo Hearing Assistance Device (HAD) First

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joshua Chodosh, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2017

First Posted

November 9, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations

US(1)