Clinical trial NCT02412254: Aging, Cognition, and Hearing Evaluation in Elders Study
Official title: Aging, Cognition, and Hearing Evaluation in Elders Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hearing Handicap Inventory for the Elderly (HHIE)
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests
timeFrame: 6 months
Other outcomes:
Locations:
city: Hagerstown
country: United States
facility: Johns Hopkins Comstock Center for Public Health Research
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Frank Lin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deal JA, Albert MS, Arnold M, Bangdiwala SI, Chisolm T, Davis S, Eddins A, Glynn NW, Goman AM, Minotti M, Mosley T, Rebok GW, Reed N, Rodgers E, Sanchez V, Sharrett AR, Coresh J, Lin FR. A randomized feasibility pilot trial of hearing treatment for reducing cognitive decline: Results from the Aging and Cognitive Health Evaluation in Elders Pilot Study. Alzheimers Dement (N Y). 2017 Jun 21;3(3):410-415. doi: 10.1016/j.trci.2017.06.003. eCollection 2017 Sep.