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

Randomized controlled trial on the effect of programmed hearing aids on cognition in older New Zealanders

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001155381
Enrollment
66
Registered
2017-08-08
Start date
2018-07-30
Completion date
2021-10-18
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Untreated hearing loss speeds up age-related decline in our ability to process & understand information. Hearing aids may slow or halt this decline. Some technology used in hearing aids requires fast thinking that can be impaired with age. We will undertake a trial comparing standard hearing aid settings to those that have been set for slower processing of sound. In a case of “less is more” when our own processing of information becomes slower hearing aid processing also needs to slow down.

Interventions

A double blind two arm 12-month randomised controlled trial comparing ‘usual care’ to a modified hearing aid fitting. The modified hearing aid fitting "CogniAid" settings:. The intervention group will receive processing with minimised signal distortion consisting of linear-slow processing (e.g. linear input-output processing, output limiting compression, non-adaptive manually selected directional microphone, moderate slow-acting noise reduction with manual program switching. The participant a

A double blind two arm 12-month randomised controlled trial comparing ‘usual care’ to a modified hearing aid fitting. The modified hearing aid fitting "CogniAid" settings:. The intervention group will receive processing with minimised signal distortion consisting of linear-slow processing (e.g. linear input-output processing, output limiting compression, non-adaptive manually selected directional microphone, moderate slow-acting noise reduction with manual program switching. The participant and clinician will decide the brand, model and technology level best suited on the basis of a hearing needs assessment. The aids will be programmed and matched to NAL-R linear hearing aid targets. If acoustic feedback occurs the ear-coupling system used (domes, ear moulds) will be modified for tighter acoustic seal before digital feedback methods are employed.

Sponsors

The University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026