Aging, Cognition, and Hearing Evaluation in Elders Study

NCT ID: NCT02412254

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2021-03-08

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hearing intervention

Best practices hearing rehabilitative treatment

Group Type: ACTIVE_COMPARATOR

Best practices hearing rehabilitative treatment

Intervention Type: OTHER

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

Successful aging intervention

Successful aging intervention

Group Type: PLACEBO_COMPARATOR

Successful aging intervention

Intervention Type: OTHER

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

Interventions

Best practices hearing rehabilitative treatment

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

Intervention Type: OTHER

Successful aging intervention

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Lin

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Comstock Center for Public Health Research

Hagerstown, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29067347 (View on PubMed)

Other Identifiers

R34AG046548

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00067383

Identifier Type: -

Identifier Source: org_study_id