Study 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.
Hearing Loss in Older Adults Study
Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.
1 other identifier
interventional
1
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2017
CompletedFirst Posted
Study publicly available on registry
December 26, 2017
CompletedStudy Start
First participant enrolled
March 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2020
CompletedResults Posted
Study results publicly available
December 22, 2022
CompletedDecember 22, 2022
November 1, 2022
9 months
December 19, 2017
September 13, 2022
November 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 months after enrollment
Study Arms (2)
Group A (Immediate Cochlear Implantation)
EXPERIMENTALGroup 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 (Delayed Cochlear Implantation)
ACTIVE COMPARATORGroup 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.
Interventions
Unilateral implantation with a commercially approved Nucleus cochlear implant
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
- CogState Ltd.collaborator
- Syneos Healthcollaborator
Study Sites (8)
Arizona Center for Neurosciences
Tucson, Arizona, 85718, United States
House Ear Institute
Los Angeles, California, 90057, United States
Washington University
St Louis, Missouri, 63112, United States
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10029, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599, United States
University of Cincinnati Health
Cincinnati, Ohio, 45219, United States
Ohio State University
Columbus, Ohio, 43212, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- PRS Specialist, Clinical Affairs
- Organization
- Cochlear Limited
Study Officials
- STUDY DIRECTOR
David N Cade, MD, MBA
Cochlear
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2017
First Posted
December 26, 2017
Study Start
March 27, 2019
Primary Completion
January 4, 2020
Study Completion
January 4, 2020
Last Updated
December 22, 2022
Results First Posted
December 22, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share