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Aging, Cognition, and Hearing Evaluation in Elders Study

Aging, Cognition, and Hearing Evaluation in Elders Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02412254
Acronym
ACHIEVE-P
Enrollment
40
Registered
2015-04-09
Start date
2015-05-31
Completion date
2021-03-08
Last updated
2021-04-08

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

Conditions

Hearing Loss

Brief summary

The investigators will conduct a small pilot study that will randomize \ 40 70-84 year-old adults with hearing loss to best-practices hearing rehabilitative treatment (hearing assessment, counseling, fitting of amplification devices) versus a successful aging intervention (one-on-one counseling/education sessions on successful aging topics). Participants will be followed for 6 months, and outcomes will focus on communication, quality of life, cognition, and other functional surveys. This pilot study is in preparation for a larger planned trial to investigate if hearing loss treatment can reduce cognitive decline and dementia in older adults.

Interventions

OTHERBest practices hearing rehabilitative treatment

Intervention comprises hearing needs assessment, counselling, sensory management with amplification devices, and rehabilitative training.

OTHERSuccessful aging intervention

One-on-one education sessions on healthy aging topics (cancer screening, smoking cessation, etc.) between a trainer and participant

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to 84 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 70-84 years. * Community-dwelling. * Fluent English-speaker. * Residency. Participants must plan to reside in the local area for the study duration (6 months). * Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a pure tone average (0.5, 1, and 2 kHz) in the better-hearing ear of ≥ 30 decibels and \<70 dB. * Word Recognition in Quiet score \>60% bilaterally. * Mini-Mental State Exam (MMSE) score ≥ 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score ≥ 25 for individuals with some college or more * Willingness to participate. Participants must be willing and able to consent to participate in the study, be willing to be randomized to either the Hearing intervention or to the Successful Aging intervention, and be willing to follow the study protocol for the duration of the trial.

Exclusion criteria

Potential candidates for enrollment who meet one or more of t he following criteria are excluded from participation in the study: * Self-reported disability in ≥ 2 or more Activities of Daily Living (ADL) * Self-reported hearing aid use in the past year (\>5 hours/week). * Vision impairment (worse than 20/40 on MN Near Vision Card). * Medical contraindication to use of hearing aids (e.g., draining ear). * Conductive hearing impairment as determined by a difference in air audiometry and bone audiometry (air-bone gap) greater than 15 dB in 2 or more contiguous frequencies in both ears. * Unwilling to wear hearing aids on a regular (i.e., daily or near daily) basis * No participants are excluded based on race or sex

Design outcomes

Primary

MeasureTime frame
Hearing Handicap Inventory for the Elderly (HHIE)6 month follow-up

Secondary

MeasureTime frame
Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026