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Hearing Loss in Older Adults Study

Primary Purpose

Hearing Loss, Sensorineural, Hearing Loss, Bilateral

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cochlear implantation
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Center for Neurosciences
  • House Ear Institute
  • Washington University
  • New York Eye and Ear Infirmary of Mount Sinai
  • University of North Carolina Chapel Hill
  • University of Cincinnati Health
  • Ohio State University
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (Immediate Cochlear Implantation)

Group B (Delayed Cochlear Implantation)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hearing Handicap
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.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2017
Last Updated
November 30, 2022
Sponsor
Cochlear
Collaborators
CogState Ltd., Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT03382769
Brief Title
Hearing Loss in Older Adults Study
Official Title
Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Early terminated due to COVID-19 public health emergency, with a patient population in vulnerable populations (older adults) seeking cochlear implantation as elective Standard of Care.
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
January 4, 2020 (Actual)
Study Completion Date
January 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
Collaborators
CogState Ltd., Syneos 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Hearing Loss, Bilateral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Immediate Cochlear Implantation)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (Delayed Cochlear Implantation)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cochlear implantation
Intervention Description
Unilateral implantation with a commercially approved Nucleus cochlear implant
Primary Outcome Measure Information:
Title
Hearing Handicap
Description
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.
Time Frame
6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David N Cade, MD, MBA
Organizational Affiliation
Cochlear
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
House Ear Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
New York Eye and Ear Infirmary of Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Cincinnati Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hearing Loss in Older Adults Study

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