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Clinical Trials/CTRI/2024/04/065271
CTRI/2024/04/065271Not yet recruitingNot Applicable

Development and validation of aural rehabilitation module for adults with hearing loss and their significant others

Spoorthi G N1 site in 1 country80 target enrollmentStarted: June 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
1. Hearing related quality of life

Study Overview

Brief Summary

The aim of the study is to develop a short-term aural rehabilitation module for adults with hearing loss and their significant others in Kannada and validate it. The objectives are to

1.     (1) To develop a short-term aural rehabilitation module in Kannada for adults with acquired hearing loss and their significant others.

2.     (2) To validate the developed aural rehabilitation module in Kannada for adults with acquired hearing loss and their significant others.

It is hypothesized that the developed aural rehabilitation module will improve various aspects of quality of life of individuals with hearing loss and their significant others.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
40.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Kannada speaking individuals with acquired bilateral hearing loss [four frequency pure tone average (500Hz, 1000Hz, 2000Hz and 4000Hz) between 26 dB HL and 90 dB HL] within the age of
  • At least “good” proficiency in Language Experience and Proficiency Questionnaire (LEAP-Q) for reading and speaking proficiency in Kannada
  • Individuals with sensorineural or mixed hearing loss
  • Speech identification scores proportional to pure tone audiometry
  • Aided audiogram at least three frequencies within speech spectrum
  • At least threesix months of experience in using hearing aids, preferably unilateral
  • Self-reported hearing aid use of 4-6 hours daily
  • Montreal Cognitive Assessment (MoCA) scores between 23 to 26.

Exclusion Criteria

  • Individuals with congenital hearing loss, unilateral hearing loss, conductive hearing loss, or profound degree of hearing loss
  • Individuals who cannot read properly due to vision problems.

Outcomes

Primary Outcomes

1. Hearing related quality of life

Time Frame: Baseline, two weeks post rehabilitation, two months post rehabilitation

2. General quality of life

Time Frame: Baseline, two weeks post rehabilitation, two months post rehabilitation

3. Communication profile

Time Frame: Baseline, two weeks post rehabilitation, two months post rehabilitation

4. Listening effort

Time Frame: Baseline, two weeks post rehabilitation, two months post rehabilitation

5. ICF activity and participation domains

Time Frame: Baseline, two weeks post rehabilitation, two months post rehabilitation

6. General fatigue

Time Frame: Baseline, two weeks post rehabilitation, two months post rehabilitation

Secondary Outcomes

  • Listening effort(Baseline, two weeks post rehabilitation, two months post rehabilitation)

Investigators

Sponsor
Spoorthi G N
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Spoorthi G N

Kasturba Medical College, Mangalore

Study Sites (1)

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