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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05025280
Other study ID # 5057087197
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date April 1, 2024

Study information

Verified date October 2023
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aimed to evaluate the sensory processing abilities of adults with acquired hearing loss and to explore the differences in sensory processing between adults with hearing loss and adults with normal hearing. Sensory processing functions of 30 adults with acquired hearing loss will be evaluated using the Adolescent/Adult Sensory Profile. The data from adults with hearing loss will be compared with data from 30 adults with normal hearing who were similar in gender and age.


Description:

This study aims to investigate the sensory processing patterns of adults with hearing loss and compare them with healthy controls. In this study, it was hypothesized that adults with hearing loss, had an abnormal sensory profile like children with hearing loss. Participants will consist of individuals between the ages of 18-65 who were taken into audiological evaluation at the outpatient unit of Audiology of a hospital and voluntarily agreed to participate in the study. According to the audiological test results, individuals with a pure tone average of more than 25 decibel (dB) in the better ear and with less than 10 dB difference between the air-bone conduction thresholds will be included in the study group, and those with a pure tone average of 25 dB or less in both ears and with less than 10 dB difference between the air-bone conduction thresholds will be included in the control group. Hearing aid users, those with chronic tinnitus and/or dizziness, and those with major medical disorders and/or handicaps will not be included in the study. In this study, Hearing Handicap Inventory for Adults (HHIA) and Adolescent/Adult Sensory Profile will be used.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date April 1, 2024
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - adults with acquired sensorineural hearing loss for study group - adults with normal hearing for control group Exclusion Criteria: - Hearing aid users - adults with chronic tinnitus and/or dizziness - adults with major medical disorders and/or handicap

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Adolescent/Adult Sensory Profile Questionnaire
The Adolescent/Adult Sensory Profile Questionnaire (AASP), was developed based on Dunn's model of sensory processing. It is a 60-item self-assessment questionnaire that evaluates behavioral patterns related to sensory processing. The questionnaire consists of six different subsections such as taste/smell processing, movement processing, visual processing, touch processing, auditory processing, and activity level. According to the answers given, individuals are evaluated in 4 quartiles as "low registration," "sensory sensitivity," "sensation avoiding," and "sensation seeking."

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adolescent/Adult Sensory Profile scores There are 15 questions in each quadrant for 60 questions in total. The responses provided are in a Likert-scale system with "almost always (5 points)", "often", "sometimes", "rarely" and "almost never (1 point)" and the scores of the related items are summed up to provide the score for each quadrant. Norm values have been established for three different age intervals: 11-18, 18-65, and 65 years and over for evaluation and respondents are classified in the end for the four quadrants using the statements "much more than most people," "more than most people," "similar to most people," "less than most people," and "much less than most people".
Respectively Sensory Processing Reference Ranges (18-64 yr)
Low registration 15-18, 19-23, 24-35, 36-44, 45-75
Sensation seeking 15-35, 36-42, 43-56, 57-62, 63-75
Sensory sensitivity 15-18, 19-25, 26-41, 42-48, 49-75
Sensation avoiding 15-19, 20-26, 27-41, 42-49, 50-75
6 months
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