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Completed

NCT Number: NCT02412254

Aging, Cognition, and Hearing Evaluation in Elders Study

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.

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Key information

Age range

70 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Comstock Center for Public Health Research

Hagerstown, Maryland, 21740, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best practices hearing rehabilitative treatment

Other

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

Successful aging intervention

Other

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

Primary outcomes

  1. Hearing Handicap Inventory for the Elderly (HHIE)

    Time frame: 6 month follow-up

Secondary outcomes

  1. Neurocognitive test battery including Trail Making Test, Delayed Word Recall, and other tests

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Aging, Cognition, and Hearing Evaluation in Elders Pilot Study

Acronym: ACHIEVE-P

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2015
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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