Sensory Processing Patterns in Hearing Loss

September 24, 2024 updated by: Bilgehan Tekin Dal, Gazi University

Sensory Processing Patterns in Adults With Acquired Hearing Loss

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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."
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
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."

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adolescent/Adult Sensory Profile scores
Time Frame: 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gonca Bumin, Prof., Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5057087197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

participant data are not to be shared with other researches

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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