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Clinical Trials/ACTRN12618001278224
ACTRN12618001278224Recruiting未知

Could hearing loss correction through the use of hearing aids decrease the 12-month rate of cognitive decline among older adults at risk of dementia?

niversity of Western Australia0 sites180 target enrollmentStarted: July 30, 2018Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Recruiting
Sponsor
Enrollment
180

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
70 Years to o limit (—)
Sex
All

Inclusion Criteria

  • Participants will be older adults aged 70 years or older (cognitive decline is more pronounced later in life).
  • Montreal Cognitive Assessment for the Hearing Impaired (MOCA-H) greater than or equal 18 and lesser than 26 (mild impairment).
  • Better ear average hearing loss at 0.5, 1 & 2 kHz (3FAHL) equal to or greater than 23 dB or high frequency average hearing loss (2, 3 & 4 kHz) (HFAHL) equal to or greater than 40 dB as measured using air conduction pure-tone audiometry. We have followed the HA fitting criteria recommended by Office of Hearing Services Australia for older adults with ARHL.
  • Fluent English speakers

Exclusion Criteria

  • Impaired instrumental activities of daily living (IADL) due to cognitive deficits (requires assistance or is dependent in the use of telephone, shopping, housekeeping, laundry, transport, management of medications and finances) – i.e. has dementia or major neurocognitive disorder
  • Meets clinical criteria for cochlear implantation (unaided bilateral sensorineural hearing loss greater than 70 dBHL, and open-set sentence scores in quiet in the worse ear less than 65% and in the better ear < 85% or open set phoneme scores in quiet in the worse ear less than 45% and in the better ear < 65% with optimized HA fitting
  • Visual impairment that limits participant’s ability to read Times New Roman font size 16 (a requirement for 2 sentences of MOCA-H)
  • Severe medical illness that limits the ability of the participant to attend appointments or sustain participation in the study for 24 months
  • Plans to move away from the study area during the subsequent 24 months
  • Unable or unwilling to provide written informed consent to participate
  • Inability to complete the motor screening task (MOT) module of the Cambridge Neuropsychological Test Battery (CANTAB) due to visual impairment, inability to comprehend test instructions or inability to attend to the task due to dexterity problems.

Investigators

Sponsor
niversity of Western Australia

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