NCT05025280

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

August 24, 2021

Last Update Submit

September 24, 2024

Conditions

Keywords

AdultHearing losssensory processing

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

hearing loss

According to the audiological test results, individuals with a pure tone average of more than 25 dB in the better ear and with less than 10 dB difference between the air-bone conduction thresholds

Other: Adolescent/Adult Sensory Profile Questionnaire

normal hearing

According to the audiological test results, individuals 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

Other: Adolescent/Adult Sensory Profile Questionnaire

Interventions

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."

hearing lossnormal hearing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

According to the audiological test results, individuals with a pure tone average of more than 25 dB in the better ear and with less than 10 dB difference between the air-bone conduction thresholds

You may qualify if:

  • adults with acquired sensorineural hearing loss for study group
  • adults with normal hearing for control group

You may not qualify if:

  • Hearing aid users
  • adults with chronic tinnitus and/or dizziness
  • adults with major medical disorders and/or handicap

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gonca Bumin, Prof.

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 27, 2021

Study Start

April 1, 2021

Primary Completion

September 1, 2021

Study Completion

January 1, 2023

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

participant data are not to be shared with other researches

Locations