Improving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT06960616
Status
Recruiting
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Conditions

  • Cochlear Hearing Loss
  • Deafness

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Changes in traditional follow-up — OTHER
    Traditional follow-up includes the following visits after activation: 1-week, 1-month, 3-months, 6-months and 1 year. With the intervention used, the 1-week follow-up is removed.
  • Population mean mapping — OTHER
    Traditional mapping at activation involves the measurement of at least 5 electrodes (both T-levels and C-levels). The intervention uses a population mean mapping strategy where there is a pre-set dynamic range of 46 CL with a spot check of C-levels.

Study Details

The study is about the importance of each follow-up visit after activating a new cochlear implant in addition to evaluating the effectiveness and efficiency of a new programming strategy from Cochlear Americas. Investigators are looking for patients who have recently selected Cochlear Americas as their cochlear implant manufacturer of choice for their upcoming surgery. The aim of this study is to determine if 1) patient outcomes remain stable when reducing follow-up appointments and 2) Cochlear's population mean mapping can produce similar outcomes with patients while additionally reducing appointment times. The hypothesis is that using population mean mapping and reducing the number of follow-up visits after activation will yield similar performance outcomes to a standard of care while decreasing the length of appointment times and number of appointments needed for each patient.

Key Dates

Start date
Feb 27, 2024
Status verified
May 2026
Primary completion
Nov 26, 2026
Completion
Feb 26, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Population mean mapping, without 1 week follow-up
    Reduction in the number of follow-up visits and new programming strategy.
  • Experimental: Population mean mapping, traditional follow-up
    New programming strategy
  • Experimental: Traditional mapping*, without 1 week follow-up
    Reduction in the number of follow-up visits.
  • No Intervention: Traditional mapping, traditional follow-up
    Traditional follow-up plan

Primary Outcome Measure

Speech perception scores [ Time Frame: 1-year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mass Eye and EarBostonMassachusetts02114
Julie Arenberg
[email protected]
617-807-7904
Julie Arenberg (PRINCIPAL_INVESTIGATOR)

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By research site
Mass Eye and Ear· Boston, MA

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