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Hearing Loss in Older Adults Study

Sponsor
Cochlear (Industry)
Overall Status
Terminated
CT.gov ID
NCT03382769
Collaborator
CogState Ltd. (Industry), Syneos Health (Other)
1
Enrollment
8
Locations
2
Arms
9.3
Actual Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cochlear implantation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.
Actual Study Start Date :
Mar 27, 2019
Actual Primary Completion Date :
Jan 4, 2020
Actual Study Completion Date :
Jan 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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

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 and followed for 6 more months after device activation.

Device: Cochlear implantation
Unilateral implantation with a commercially approved Nucleus cochlear implant

Outcome Measures

Primary Outcome Measures

  1. Hearing Handicap [6 months after enrollment]

    Assessment of the impact of cochlear implantation versus continued hearing aid use on hearing handicap as measured on the Speech, Spatial, and Qualities of Hearing (SSQ12)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arizona Center for Neurosciences Tucson Arizona United States 85718
2 House Ear Institute Los Angeles California United States 90057
3 Washington University Saint Louis Missouri United States 63112
4 New York Eye and Ear Infirmary of Mount Sinai New York New York United States 10029
5 University of North Carolina Chapel Hill Chapel Hill North Carolina United States 27599
6 University of Cincinnati Health Cincinnati Ohio United States 45219
7 Ohio State University Columbus Ohio United States 43212
8 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Cochlear
  • CogState Ltd.
  • Syneos Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cochlear
ClinicalTrials.gov Identifier:
NCT03382769
Other Study ID Numbers:
  • CLTD5693
First Posted:
Dec 26, 2017
Last Update Posted:
Oct 20, 2021
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Bilateral

Study Results

No Results Posted as of Oct 20, 2021