Hearing Loss in Older Adults Study

November 30, 2022 updated by: Cochlear

Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.

This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85718
        • Arizona Center for Neurosciences
    • California
      • Los Angeles, California, United States, 90057
        • House Ear Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63112
        • Washington University
    • New York
      • New York, New York, United States, 10029
        • New York Eye and Ear Infirmary of Mount Sinai
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Health
      • Columbus, Ohio, United States, 43212
        • Ohio State University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years to 83 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Community-dwelling
  • Proficient in English
  • Oral communicator
  • PTA (500, 1000 & 2000 Hz) ≥ 70 dB HL hearing loss duration ≥1 and no more than 30 years
  • Active daily hearing aid users
  • HHIE-S score greater than or equal to 24
  • MoCA score greater than or equal to 20
  • Post-linguistic onset sensorineural hearing loss and meet applicable FDA and/or Medicare candidacy criteria for cochlear implantation
  • Willing to consent for the study, to be randomized to either group, to utilize bimodal hearing for the duration of the trial (if clinically appropriate), and follow the study protocol

Exclusion Criteria:

  • Prelingual or perilingual severe-to-profound hearing loss
  • Previous cochlear implantation in either ear
  • Hearing loss of neural or central origin
  • Permanent conductive hearing impairment (e.g. otosclerosis)
  • Medical, audiological, or psychological conductions that might contraindicate participation in the clinical investigation
  • Self reported disability in 2 or more activities of daily living
  • Vision impairment worse than 20/40 on a near vision card

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Immediate Cochlear Implantation)
Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation.
Device: Cochlear implantation
Unilateral implantation with a commercially approved Nucleus cochlear implant
Active Comparator: Group B (Delayed Cochlear Implantation)
Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation.
Device: Cochlear implantation
Unilateral implantation with a commercially approved Nucleus cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Handicap
Time Frame: 6 months after enrollment

The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item.

Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Collaborators

CogState Ltd.
Syneos Health

Investigators

  • Study Director: David N Cade, MD, MBA, Cochlear

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2019

Primary Completion (Actual)

January 4, 2020

Study Completion (Actual)

January 4, 2020

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

December 22, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTD5693

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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