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Hearing Loss in Older Adults Study

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ClinicalTrials.gov Identifier: NCT03382769
Recruitment Status : Not yet recruiting
First Posted : December 26, 2017
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
CogState Ltd.
Syneos Health
Information provided by (Responsible Party):
Cochlear

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
Hearing Loss, Sensorineural Hearing Loss, Bilateral Device: Cochlear implantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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.
Estimated Study Start Date : March 2, 2019
Estimated Primary Completion Date : August 2, 2021
Estimated Study Completion Date : February 2, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Hearing Handicap [ Time Frame: 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)



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382769


Contacts
Contact: Michelle Knight, B.Sc. Dip.Aud. +61386623110 mknight@cochlear.com
Contact: Kimberly Nix, AuD 303-264-2340 knix@cochlear.com

Locations
United States, California
House Ear Institute Not yet recruiting
Los Angeles, California, United States, 90057
Contact: Eric Wilkinson, MD    213-483-9930    ewilkinson@houseclinic.com   
Contact: John Galvin, PhD    310-666-7573    jgalvin@hei.org   
Sponsors and Collaborators
Cochlear
CogState Ltd.
Syneos Health

Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT03382769     History of Changes
Other Study ID Numbers: CLTD5693
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms