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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338751
Recruitment Status : Withdrawn (Unfunded Pilot Study)
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hearing Impairment Diagnostic Test: cognitive testing with HAD (PockeTalker) First Diagnostic Test: Cognitive testing without HAD First Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hearing Assistance Device (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.
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.
Other Name: PockeTalker Hearing Aid Device

Diagnostic Test: 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.

Active Comparator: No Hearing Assistance Device (HAD) First
Sham hearing aid device
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.
Other Name: PockeTalker Hearing Aid Device

Diagnostic Test: 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.




Primary Outcome Measures :
  1. Measure of Cognitive function using Mini-Cog [ Time Frame: 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.

  2. Perceived Hearing measured by Hearing Handicap Inventory for the Elderly-Screening Version (HHIE) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338751


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Joshua Chodosh, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03338751     History of Changes
Other Study ID Numbers: 17-00697
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms