Aging, Cognition, and Hearing Evaluation in Elders Study
Completed · Not applicable
Conditions studied: Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT02412254
- Run by
- Johns Hopkins University
- People needed
- 40
- Starts
- 2015-05-01
- Expected to finish
- 2021-03-08
- Last updated by the study team
- 2021-04-08
Who can join
Age: 70 and older, up to 84. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Comstock Center for Public Health Research — Hagerstown, Maryland, United States
Full record on ClinicalTrials.gov
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