Hearing in NoiseNCT07756970
Speech Perception, Spatial Perception and Satisfaction Outcomes of Fitting Based on Hearing In Noise Ability
A study testing ACT method in fitting and Traditional fitting in people with Hearing in Noise, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
Hearing speech in the presence of background noise is a significant challenge for those with hearing loss. Being able to hear speech in noise has been rated as the most sought-after feature in hearing aids by hearing aid users. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Hearing in Noise
- What is being tested?
- ACT method in fitting and Traditional fitting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2025to 1 Jun 2025
- Phase
- Interventional
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medium (41-55 dB) / moderate to severe (56-70 dB), sensorineural hearing loss (Goodman, 1965)
- SDS score between 70-100%
- Being a bilateral hearing aid user
- Being a user of Oticon, Philips, Bernafon hearing aids
- Being between 18-50 years of age
- Signing an informed consent form
Who cannot join
- Conditions with variable hearing loss such as Meniere's disease, ongoing treatment with ototoxic drugs
- Complaining with tinnitus
- Low cognitive capacity: Scoring below 24 on the Standardized Mini Mental Test
- Not signing an informed consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydın University
Istanbul, Kucukcekmece, 34295
About this study
Hearing speech in the presence of background noise is a significant challenge for those with hearing loss. Being able to hear speech in noise has been rated as the most sought-after feature in hearing aids by hearing aid users. Our study aims to evaluate the effects of adaptation to hearing test in noise on speech perception, spatial perception and satisfaction in bilateral hearing aid users. The development process of speech understanding in noise in individuals with hearing loss over the age of 50 will be monitored with ACT and ecological-HINT tests. Spatial perception will be assessed with the Speech, Spatial Perception and Hearing Quality (SHRQ) Scale, which is a scale that evaluates the current hearing quality in adults. The hearing aid satisfaction process of the participants will be assessed with the APHAB survey.
Read the detailed description
Hypotheses:
H0: Using ACT in the fitting is not more effective than the traditional fitting method in improving speech understanding performance in noise in hearing aid users.
H1: Using ACT in the fitting is more effective than the traditional fitting method in improving speech understanding performance in noise in hearing aid users.
H0: Using ACT in the fitting is not more effective than the traditional fitting method in improving spatial perception performance in hearing aid users.
H1: Using ACT in the fitting is more effective than the traditional fitting method in improving spatial perception performance in hearing aid users.
H0: Using ACT in the fitting does not increase speech understanding performance in noise in hearing aid users.
H1: Using ACT in the fitting increases speech understanding performance in noise in hearing aid users.
H0: Using ACT in the fitting has no effect on improving spatial perception performance in hearing aid users.
H1: Using ACT in the fitting has an effect on improving spatial perception performance in hearing aid users.
H0: Using ACT in fitting has no effect on increasing hearing aid satisfaction in hearing aid users.
H1: Using ACT in fitting has an effect on increasing hearing aid satisfaction in hearing aid users.
- Conditions
- Hearing in Noise
- Being tested
- ACT method in fitting, Traditional fitting
- Keywords
- audible contrast threshold, hearing aid, hearing in noise, eko-HINT, spatial perception
- Medical subject headings
- Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT method in fittingDiagnostic test
Also called hearing in noise
The ACT diagnostic test is a suprathreshold, non-language-specific test that measures an individual's hearing ability in real-world noisy environments to determine the level of assistance needed in noise. The test uses the audiogram shape and levels to ensure the correct stimulus intensity is applied. The ACT test then uses the patient's audiogram to present a suprathreshold stimulus (a siren-like sound) to objectively map their hearing ability in noisy environments. In other words, the audiogram measures quantity, i.e. hearing ability, while the ACT measures the quality of hearing. This makes the ACT a robust assessment that reflects an individual's real-world hearing abilities.
Traditional fittingDiagnostic test
The control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting. They will be called for a check-up at week 1 and month 1, and fitting and scale assessments will be made, and the results will be recorded. Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1. All findings will be compared and statistically analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Active comparator | The ACT method will be applied to the study group in fitting, and the results will be recorded by applying the KUİK scale and APHAB survey after fitting. They will be called for control in the 1st week and 1st month, and fitting and scale evaluations will be made and the results will be recorded. Participants' discrimination in noise with ACT and Turkish Matrix Test, evaluation of spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be evaluated in the initial and 1st month time periods. Receives: Diagnostic Test: ACT method in fitting |
| Control Group | Active comparator | The control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting. Fitting and scale assessments will be made at week 1 and month 1, and the results will be recorded. Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception assessment with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1. Receives: Diagnostic Test: Traditional fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eco-HINT
Speech-in-noise performance was assessed using the ecologically valid Hearing in Noise Test (eco-HINT). Speech reception thresholds were measured under aided and unaided listening conditions. Lower scores indicate better speech-in-noise performance.
Measured: 1 week and 1 month after hearing aid fitting
Secondary outcomes (2)
Speech, Spatial Perception and Hearing Quality Scale
The individual who is applied the scale evaluates himself/herself and answers each question between 0 and 10 points. All scores are added up and divided by 49 to obtain the "General KUİK score". The scores under the heading of Speech Perception are added up and divided by 14 to obtain the KA score, the scores under the heading of Spatial Perception are added up and divided by 17 to obtain the UA score, and the scores under the heading of Hearing Quality are added up and divided by 18 to obtain the İK score.
Measured: 1 week and 1 month after hearing aid fitting
APHAB survey
APHAB is a survey that allows us to numerically measure the benefits and satisfaction of individuals with hearing loss from their hearing aids in daily hearing situations. Survey questions are answered according to two different listening situations: "without my hearing aid" and "with my hearing aid".
Measured: 1 week and 1 month after hearing aid fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start13 Feb 2025
- Primary completion2 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing in NoiseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Inclusion Criteria: Medium (41-55 dB) / moderate to severe (56-70 dB), sensorineural hearing loss (Goodman, 1965) SDS score between 70-100% Being a bilateral hearing aid user Being a user of Oticon, Philips, Bernafon hearing aids Being between 18-50 years of age Signing an informed consent form Exclusion Criteria: Conditions with variable hearing loss such as Meniere's disease, ongoing treatment with ototoxic drugs Complaining with tinnitus Low cognitive capacity: Scoring below 24 on the Standardized Mini Mental Test Not signing an informed consent form The ACT method will be applied to the study group in fitting, the KUİK scale and APHAB survey will be applied after fitting and the results will be recorded. The control group will be applied with traditional fitting, the KUİK scale and APHAB survey will be applied after fitting and the results will be recorded.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Başak ÖZKAN, Istanbul Aydın University
- Investigators
- Sule Cekic, associate professor, Study director, Ankara Yildirim Beyazıt UniversityUmıt Can Cetinkaya, assistant professor, Study director, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756970
- Sponsor's protocol ID
- 61351342/020-385
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure the privacy and confidentiality of participants, individual participant data (IPD) will not be shared. Since the study involves hearing aid users, it is extremely important to protect the integrity of their personal data. Furthermore, the guidelines of the ethics committee and institutional policies require strict data protection to prevent possible misuse. Therefore, IPD will remain confidential and will not be made public.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Perception, Spatial Perception and Satisfaction Outcomes of Fitting Based on Hearing In Noise Ability
- ClinicalTrials.gov ID
- NCT07756970
- Acronym / sponsor ID
- 61351342/020-385
- Conditions
- Hearing in Noise
- Keywords
- audible contrast threshold, hearing aid, hearing in noise, eko-HINT, spatial perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 11 Aug 2026 (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.
Hearing speech in the presence of background noise is a significant challenge for those with hearing loss. Being able to hear speech in noise has been rated as the most sought-after feature in hearing aids by hearing aid users. Our study aims to evaluate the effects of adaptation to hearing test in noise on speech perception, spatial perception and satisfaction in bilateral hearing aid users. The development process of speech understanding in noise in individuals with hearing loss over the age of 50 will be monitored with ACT and ecological-HINT tests. Spatial perception will be assessed with the Speech, Spatial Perception and Hearing Quality (SHRQ) Scale, which is a scale that evaluates the current hearing quality in adults. The hearing aid satisfaction process of the participants will be assessed with the APHAB survey.
Detailed description
Hypotheses:
H0: Using ACT in the fitting is not more effective than the traditional fitting method in improving speech understanding performance in noise in hearing aid users.
H1: Using ACT in the fitting is more effective than the traditional fitting method in improving speech understanding performance in noise in hearing aid users.
H0: Using ACT in the fitting is not more effective than the traditional fitting method in improving spatial perception performance in hearing aid users.
H1: Using ACT in the fitting is more effective than the traditional fitting method in improving spatial perception performance in hearing aid users.
H0: Using ACT in the fitting does not increase speech understanding performance in noise in hearing aid users.
H1: Using ACT in the fitting increases speech understanding performance in noise in hearing aid users.
H0: Using ACT in the fitting has no effect on improving spatial perception performance in hearing aid users.
H1: Using ACT in the fitting has an effect on improving spatial perception performance in hearing aid users.
H0: Using ACT in fitting has no effect on increasing hearing aid satisfaction in hearing aid users.
H1: Using ACT in fitting has an effect on increasing hearing aid satisfaction in hearing aid users.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Inclusion Criteria: Medium (41-55 dB) / moderate to severe (56-70 dB), sensorineural hearing loss (Goodman, 1965) SDS score between 70-100% Being a bilateral hearing aid user Being a user of Oticon, Philips, Bernafon hearing aids Being between 18-50 years of age Signing an informed consent form Exclusion Criteria: Conditions with variable hearing loss such as Meniere's disease, ongoing treatment with ototoxic drugs Complaining with tinnitus Low cognitive capacity: Scoring below 24 on the Standardized Mini Mental Test Not signing an informed consent form The ACT method will be applied to the study group in fitting, the KUİK scale and APHAB survey will be applied after fitting and the results will be recorded. The control group will be applied with traditional fitting, the KUİK scale and APHAB survey will be applied after fitting and the results will be recorded.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Active comparator | Diagnostic Test: ACT method in fittingThe ACT method will be applied to the study group in fitting, and the results will be recorded by applying the KUİK scale and APHAB survey after fitting. They will be called for control in the 1st week and 1st month, and fitting and scale evaluations will be made and the results will be recorded. Participants' discrimination in noise with ACT and Turkish Matrix Test, evaluation of spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be evaluated in the initial and 1st month time periods. |
| Control Group | Active comparator | Diagnostic Test: Traditional fittingThe control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting. Fitting and scale assessments will be made at week 1 and month 1, and the results will be recorded. Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception assessment with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Medium (41-55 dB) / moderate to severe (56-70 dB), sensorineural hearing loss (Goodman, 1965)
- SDS score between 70-100%
- Being a bilateral hearing aid user
- Being a user of Oticon, Philips, Bernafon hearing aids
- Being between 18-50 years of age
Key exclusion criteria (4 listed)
- Conditions with variable hearing loss such as Meniere's disease, ongoing treatment with ototoxic drugs
- Complaining with tinnitus
- Low cognitive capacity: Scoring below 24 on the Standardized Mini Mental Test
- Not signing an informed consent form
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 |
|---|---|---|
| ACT method in fittingAlso: hearing in noiseThe ACT diagnostic test is a suprathreshold, non-language-specific test that measures an individual's hearing ability in real-world noisy environments to determine the level of assistance needed in noise. The test uses the audiogram shape and levels to ensure the correct stimulus intensity is applied. The ACT test then uses the patient's audiogram to present a suprathreshold stimulus (a siren-like sound) to objectively map their hearing ability in noisy environments. In other words, the audiogram measures quantity, i.e. hearing ability, while the ACT measures the quality of hearing. This makes the ACT a robust assessment that reflects an individual's real-world hearing abilities. | Diagnostic test | Experimental Group |
| Traditional fittingThe control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting. They will be called for a check-up at week 1 and month 1, and fitting and scale assessments will be made, and the results will be recorded. Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1. All findings will be compared and statistically analyzed. | Diagnostic test | Control Group |
Primary outcome
Eco-HINT
Time frame: 1 week and 1 month after hearing aid fitting
Speech-in-noise performance was assessed using the ecologically valid Hearing in Noise Test (eco-HINT). Speech reception thresholds were measured under aided and unaided listening conditions. Lower scores indicate better speech-in-noise performance.
2 secondary outcomes
Speech, Spatial Perception and Hearing Quality Scale
Time frame: 1 week and 1 month after hearing aid fitting
APHAB survey
Time frame: 1 week and 1 month after hearing aid fitting
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 11 Aug 2026.
- The Audible Contrast Threshold (ACT) test: A clinical spectro-temporal modulation detection testLink provided by the sponsor.
- Individual participant dataSharing planned: No. To ensure the privacy and confidentiality of participants, individual participant data (IPD) will not be shared. Since the study involves hearing aid users, it is extremely important to protect the integrity of their personal data. Furthermore, the guidelines of the ethics committee and institutional policies require strict data protection to prevent possible misuse. Therefore, IPD will remain confidential and will not be made public.
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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.
Sule Cekic, associate professor study director
Ankara Yildirim Beyazıt University
Umıt Can Cetinkaya, assistant professor study director
Istanbul Aydın University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT method in fitting and Traditional fitting in people with Hearing in Noise, run by Istanbul Aydın 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 6 inclusion and 4 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 11 Aug 2026. 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?
Eco-HINT (time frame: 1 week and 1 month after hearing aid fitting). 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 11 Aug 2026.