Effect of programmed hearing aids on the brain: the CogniAid trial

Not Applicable

Completed

• Conditions: Hearing loss; Reduced cognitive reserve; Ear - Other ear disorders

• Registration Number: ACTRN12617001155381
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Study Completion: 2021-12-06
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Participants will be new hearing aid users aged 65 or older, and have below median NIH toolbox age-adjusted composite cognition scores

Exclusion Criteria

Persons with median and greater NIH toolbox composite cognition scores will be excluded from the trial. Current hearing aid users will not be recruited. Persons with fluctuating hearing loss or fast-progressing ongoing otologic disease or requiring referrals to psychiatric or mental health services will be excluded. Persons with severe-profound hearing loss sufficient to make auditory cognition test materials inaudible will not be included. Persons unable to manually adjust aids using controls on the aid or remote control will be excluded. Persons with previous history of stroke or traumatic brain injury are excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the NIH toolbox age-adjusted composite cognitive score . These measures will be obtained using the iPad based NIH APP. The age adjusted Cognitive Function Composite score is comprised of several components, derived standard scores are based on the composite distribution and corrected relative age-related norms. [12 months]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures will include changes in the NIH tool-box age adjusted composite cognitive score at 6 and 12 months. [6 and 12 months];HHIE-S, a hearing questionnaire.[6 and 12 months];WIN (Word in noise test).[6 and 12 months];MAPHAB a hearing questionnaire.[6 and 12 Months];Hours of hearing aid use determined using the on-board datalogging recordings of the hearing aids. [Continuous measurement for 12 months, the hearing aids record useage as hours or minutes, depending on model. The measure is continuous, hours of use will be recorded at 6 and 12 months.]