Hearing Loss in Older Adults Study

Hearing Loss, Sensorineural Clinical Trial

Official title:

Hearing Loss in Older Adults: A Randomized Controlled Trial of Immediate Versus Delayed Cochlear Implantation.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03382769
• Other study ID #: CLTD5693
• Status: Terminated
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: January 4, 2020

Study information

• Verified date: November 2022
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 4, 2020
• Est. primary completion date: January 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	University of Cincinnati Health	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	House Ear Institute	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	New York Eye and Ear Infirmary of Mount Sinai	New York	New York
United States	Washington University	Saint Louis	Missouri
United States	Arizona Center for Neurosciences	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Cochlear	CogState Ltd., Syneos Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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