Status:
TERMINATED
Hearing Loss in Older Adults Study
Lead Sponsor:
Cochlear
Collaborating Sponsors:
CogState Ltd.
Syneos Health
Conditions:
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Eligibility:
All Genders
65-85 years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03382769
Start Date
March 27 2019
End Date
January 4 2020
Last Update
December 22 2022
Active Locations (8)
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1
Arizona Center for Neurosciences
Tucson, Arizona, United States, 85718
2
House Ear Institute
Los Angeles, California, United States, 90057
3
Washington University
St Louis, Missouri, United States, 63112
4
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States, 10029