Hearing LossNCT05025280
Sensory Processing Patterns in Hearing Loss
An observational study of Hearing Loss, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Adolescent/Adult Sensory Profile Questionnaire
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Jan 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- adults with acquired sensorineural hearing loss for study group
- adults with normal hearing for control group
Who cannot join
- Hearing aid users
- adults with chronic tinnitus and/or dizziness
- adults with major medical disorders and/or handicap
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Adolescent/Adult Sensory Profile Questionnaire
- Keywords
- Adult, Hearing loss, sensory processing
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent/Adult Sensory Profile QuestionnaireOther
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."
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Adolescent/Adult Sensory Profile Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Apr 2021
- Primary completion1 Sep 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilgehan Tekin Dal, Gazi University
- Investigators
- Gonca Bumin, Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025280
- Sponsor's protocol ID
- 5057087197
- Status last verified
- Sep 2024
- First submitted
- 24 Aug 2021
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participant data are not to be shared with other researches
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Processing Patterns in Adults With Acquired Hearing Loss
- ClinicalTrials.gov ID
- NCT05025280
- Acronym / sponsor ID
- 5057087197
- Conditions
- Hearing Loss
- Keywords
- Adult, Hearing loss, sensory processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hearing loss | – | Other: Adolescent/Adult Sensory Profile QuestionnaireAccording 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 |
| normal hearing | – | Other: Adolescent/Adult Sensory Profile QuestionnaireAccording 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- adults with acquired sensorineural hearing loss for study group
- adults with normal hearing for control group
Key exclusion criteria (3 listed)
- Hearing aid users
- adults with chronic tinnitus and/or dizziness
- adults with major medical disorders and/or handicap
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adolescent/Adult Sensory Profile QuestionnaireThe 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." | Other | hearing loss, normal hearing |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No. participant data are not to be shared with other researches
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonca Bumin, Prof. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent/Adult Sensory Profile scores (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.