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

Primary Purpose

Hearing Impairment

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive testing with HAD (PockeTalker) First
Cognitive testing without HAD First
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hearing Assistance Device (HAD) First

No Hearing Assistance Device (HAD) First

Arm 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.

Sham hearing aid device

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2017
Last Updated
November 8, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03338751
Brief Title
Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents
Acronym
DECIPHER
Official Title
Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Unfunded Pilot Study
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hearing Assistance Device (HAD) First
Arm Type
Active Comparator
Arm 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.
Arm Title
No Hearing Assistance Device (HAD) First
Arm Type
Active Comparator
Arm Description
Sham hearing aid device
Intervention Type
Diagnostic Test
Intervention Name(s)
cognitive testing with HAD (PockeTalker) First
Other Intervention Name(s)
PockeTalker Hearing Aid Device
Intervention Description
tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cognitive testing without HAD First
Intervention Description
tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
Primary Outcome Measure Information:
Title
Measure of Cognitive function using Mini-Cog
Description
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.
Time Frame
20 Minutes
Title
Perceived Hearing measured by Hearing Handicap Inventory for the Elderly-Screening Version (HHIE)
Description
HHIE-S is a valid, robust test for identifying hearing-impaired elderly, irrespective of the audiometric definition used to finally diagnose hearing difficulties.
Time Frame
20 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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