Hearing ImpairmentDECIPHERNCT03338751
Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents
A study testing cognitive testing with HAD (PockeTalker) First and Cognitive testing without HAD First in people with Hearing Impairment, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- cognitive testing with HAD (PockeTalker) First and Cognitive testing without HAD First
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2018to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- not on the unit of intervention
- obtunded or comatose state
- inability to communicate verbally
- inability to consent and without surrogate
- non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Hearing Impairment
- Being tested
- cognitive testing with HAD (PockeTalker) First, Cognitive testing without HAD First
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive testing with HAD (PockeTalker) FirstDiagnostic test
Also called PockeTalker Hearing Aid Device
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 FirstDiagnostic test
tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: cognitive testing with HAD (PockeTalker) First; Diagnostic Test: Cognitive testing without HAD First |
| No Hearing Assistance Device (HAD) First | Active comparator | Sham hearing aid device Receives: Diagnostic Test: cognitive testing with HAD (PockeTalker) First; Diagnostic Test: Cognitive testing without HAD First |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 20 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study startJan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: Unfunded Pilot Study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Chodosh, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338751
- Sponsor's protocol ID
- 17-00697
- Acronym
- DECIPHER
- Status last verified
- Nov 2017
- First submitted
- 27 Oct 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents
- ClinicalTrials.gov ID
- NCT03338751
- Acronym / sponsor ID
- DECIPHER / 17-00697
- Conditions
- Hearing Impairment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unfunded Pilot Study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing Assistance Device (HAD) First | Active comparator | Diagnostic Test: cognitive testing with HAD (PockeTalker) First, Diagnostic Test: Cognitive testing without HAD FirstTablet, 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 | Active comparator | Diagnostic Test: cognitive testing with HAD (PockeTalker) First, Diagnostic Test: Cognitive testing without HAD FirstSham hearing aid device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- not on the unit of intervention
- obtunded or comatose state
- inability to communicate verbally
- inability to consent and without surrogate
- non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive testing with HAD (PockeTalker) FirstAlso: PockeTalker Hearing Aid Devicetablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second. | Diagnostic test | Hearing Assistance Device (HAD) First, No Hearing Assistance Device (HAD) First |
| Cognitive testing without HAD Firsttablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second. | Diagnostic test | Hearing Assistance Device (HAD) First, No Hearing Assistance Device (HAD) First |
Primary outcome
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Chodosh, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive testing with HAD (PockeTalker) First and Cognitive testing without HAD First in people with Hearing Impairment, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Cognitive function using Mini-Cog (time frame: 20 Minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.