Hearing Loss, Age-RelatedNCT07798453
Communication Training in Hearing Aid Users
A study testing Cognitive screening, Audiological Assessment and Questionnaires in people with Hearing Loss, Age-Related and Hearing Aids, run by University Ghent at 1 site in Belgium.
Trial summary
The objective of the current research project is to investigate the effectiveness of communication training in first-time hearing aid users with mild to moderate hearing loss delivered in-person in groups or individually. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Hearing Loss, Age-Related, Hearing Aids, Sensorineural Hearing Loss
- What is being tested?
- Cognitive screening, Audiological Assessment and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Sep 2025to 9 Jul 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dutch speaking first-time hearing aid users between 45-80 years
- Individuals with mild-to-moderate sensorineural hearing loss
- Individuals with bilateral hearing aids (minimal 6 months)
- Individuals who are capable to give consent to participate in the study themselves
Who cannot join
- User of cochlear implants
- Participants who have previously received auditory, auditory-cognitive, or communication training
- Participants with a middle ear disorder
- Participants without age-appropriate cognition
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the current research project is to investigate the effectiveness of communication training in first-time hearing aid users with mild to moderate hearing loss delivered in-person in groups or individually. In doing so, the project aims to strengthen evidence-based person-centered care for individuals with hearing loss and pave the path toward more holistic hearing healthcare.
We hypothesize that participants receiving communication training will show improved hearing-related quality of life, communication strategies, and personal adjustment compared to controls. Moreover, group training is expected to yield greater benefits in communication strategies and adjustment than individual training, due to its interactive nature and peer support, leading to more positive evaluations in interviews.
A pretest-posttest design will be used, with testing before and after the communication training sessions, and two experimental groups and a control group. The two experimental groups are the groups receiving in-person group and individual training. The control group does not receive the communication training nor an alternative. A mixed-method will be applied to collect quantitative and qualitative data. The quantitative data include screening measures, audiological tests, and questionnaires, while the qualitative data consist of a semi-structured interview.
- Conditions
- Hearing Loss, Age-Related, Hearing Aids, Sensorineural Hearing Loss, Speech Intelligibility, Quality of Life Outcomes
- Being tested
- Cognitive screening, Audiological Assessment, Questionnaires, Communication training, Interview
- Medical subject headings
- Presbycusis, Hearing Loss, Sensorineural, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive screeningBehavioural
The Dutch Montreal Cognitive Assessment will be assessed.
Audiological AssessmentBehavioural
- Tympanometry
- Otoscopy
- Pure-tone audiometry
- Speech audiometry in quiet and in noise
QuestionnairesBehavioural
5 questionnaires are included (Dutch translation):
- The hAVICOP questionnaire to assess the hearing-related quality of life for Auditory-Visual, Cognitive and Psychosocial functioning
- The Revised Hearing Handicap Inventory for Adults (RHHI-A)
- The Communication Profile for the Hearing Impaired (CPHI)
- The Hearing Attitudes in Rehabilitation Questionnaire (HARQ)
- The International OutcomeInventory for Hearing Aids (IOI-HA)
Communication trainingBehavioural
The participant will take part in two training sessions. Depending on the assigned group, this will take place individually or in a group setting. During the training, challenges commonly faced by people with hearing loss will be discussed, and strategies to communicate more effectively will be introduced.
InterviewOther
A semi-structured one-on-one interviews will be conducted. Participants in the group and individual training will be asked about the feasibility, usability, and effectiveness of the training they attended. Participants in the control group, who did not receive training, will be asked about their expectations regarding a communication training.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The control group does not receive the communication training nor an alternative. Receives: Behavioral: Cognitive screening; Behavioral: Audiological Assessment; Behavioral: Questionnaires; Behavioral: Communication training; Other: Interview |
| Group with individual communication training | Experimental | The individuals receive individual training. Receives: Behavioral: Cognitive screening; Behavioral: Audiological Assessment; Behavioral: Questionnaires; Behavioral: Communication training; Other: Interview |
| Group with group communication training | Experimental | The individuals receive group training. Receives: Behavioral: Cognitive screening; Behavioral: Audiological Assessment; Behavioral: Questionnaires; Behavioral: Communication training; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing related quality of life questionnaire
Higher scores mean a better outcome.
Measured: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).
International Outcome Inventory for Hearing Aids Questionnaire
Higher scores mean a better outcome.
Measured: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).
Hearing Attitudes in Rehabilitation Questionnaire
Higher scores mean a worse outcome.
Measured: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).
Hearing Handicap Inventory for the Elderly Screening Questionnaire
Higher scores mean a worse outcome.
Measured: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).
Communication Profile for the Hearing Impaired Questionnaire
Higher scores mean a better outcome.
Measured: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).
Interview about training
Measured: This outcome measure will be assessed once: once during the post testing (+/- 7 to 8 weeks after the baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start16 Sep 2025
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Age-RelatedStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Sonova AG
- Responsible party
- Sponsor
- Investigators
- Hannah Keppler, Prof. dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798453
- Sponsor's protocol ID
- ONZ-2024-0234 (AM)
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Training in Hearing Aid Users
- ClinicalTrials.gov ID
- NCT07798453
- Acronym / sponsor ID
- ONZ-2024-0234 (AM)
- Conditions
- Hearing Loss, Age-Related, Hearing Aids, Sensorineural Hearing Loss, Speech Intelligibility, Quality of Life Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Sonova AG
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 1 Sep 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.
The objective of the current research project is to investigate the effectiveness of communication training in first-time hearing aid users with mild to moderate hearing loss delivered in-person in groups or individually. In doing so, the project aims to strengthen evidence-based person-centered care for individuals with hearing loss and pave the path toward more holistic hearing healthcare.
We hypothesize that participants receiving communication training will show improved hearing-related quality of life, communication strategies, and personal adjustment compared to controls. Moreover, group training is expected to yield greater benefits in communication strategies and adjustment than individual training, due to its interactive nature and peer support, leading to more positive evaluations in interviews.
A pretest-posttest design will be used, with testing before and after the communication training sessions, and two experimental groups and a control group. The two experimental groups are the groups receiving in-person group and individual training. The control group does not receive the communication training nor an alternative. A mixed-method will be applied to collect quantitative and qualitative data. The quantitative data include screening measures, audiological tests, and questionnaires, while the qualitative data consist of a semi-structured interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Behavioral: Cognitive screening, Behavioral: Audiological Assessment, Behavioral: Questionnaires, Behavioral: Communication training, Other: InterviewThe control group does not receive the communication training nor an alternative. |
| Group with individual communication training | Experimental | Behavioral: Cognitive screening, Behavioral: Audiological Assessment, Behavioral: Questionnaires, Behavioral: Communication training, Other: InterviewThe individuals receive individual training. |
| Group with group communication training | Experimental | Behavioral: Cognitive screening, Behavioral: Audiological Assessment, Behavioral: Questionnaires, Behavioral: Communication training, Other: InterviewThe individuals receive group training. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dutch speaking first-time hearing aid users between 45-80 years
- Individuals with mild-to-moderate sensorineural hearing loss
- Individuals with bilateral hearing aids (minimal 6 months)
- Individuals who are capable to give consent to participate in the study themselves
Key exclusion criteria (4 listed)
- User of cochlear implants
- Participants who have previously received auditory, auditory-cognitive, or communication training
- Participants with a middle ear disorder
- Participants without age-appropriate cognition
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 |
|---|---|---|
| Cognitive screeningThe Dutch Montreal Cognitive Assessment will be assessed. | Behavioural | Control group, Group with group communication training, Group with individual communication training |
| Audiological Assessment1. Tympanometry 2. Otoscopy 3. Pure-tone audiometry 4. Speech audiometry in quiet and in noise | Behavioural | Control group, Group with group communication training, Group with individual communication training |
| Questionnaires5 questionnaires are included (Dutch translation): 1. The hAVICOP questionnaire to assess the hearing-related quality of life for Auditory-Visual, Cognitive and Psychosocial functioning 2. The Revised Hearing Handicap Inventory for Adults (RHHI-A) 3. The Communication Profile for the Hearing Impaired (CPHI) 4. The Hearing Attitudes in Rehabilitation Questionnaire (HARQ) 5. The International OutcomeInventory for Hearing Aids (IOI-HA) | Behavioural | Control group, Group with group communication training, Group with individual communication training |
| Communication trainingThe participant will take part in two training sessions. Depending on the assigned group, this will take place individually or in a group setting. During the training, challenges commonly faced by people with hearing loss will be discussed, and strategies to communicate more effectively will be introduced. | Behavioural | Control group, Group with group communication training, Group with individual communication training |
| InterviewA semi-structured one-on-one interviews will be conducted. Participants in the group and individual training will be asked about the feasibility, usability, and effectiveness of the training they attended. Participants in the control group, who did not receive training, will be asked about their expectations regarding a communication training. | Other | Control group, Group with group communication training, Group with individual communication training |
Primary outcome
Hearing related quality of life questionnaire
Time frame: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).
Higher scores mean a better outcome.
International Outcome Inventory for Hearing Aids Questionnaire
Time frame: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).
Higher scores mean a better outcome.
Hearing Attitudes in Rehabilitation Questionnaire
Time frame: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).
Higher scores mean a worse outcome.
Hearing Handicap Inventory for the Elderly Screening Questionnaire
Time frame: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).
Higher scores mean a worse outcome.
Communication Profile for the Hearing Impaired Questionnaire
Time frame: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).
Higher scores mean a better outcome.
Interview about training
Time frame: This outcome measure will be assessed once: once during the post testing (+/- 7 to 8 weeks after the baseline).
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 1 Sep 2026.
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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.
Hannah Keppler, Prof. dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive screening, Audiological Assessment and Questionnaires in people with Hearing Loss, Age-Related and Hearing Aids, run by University Ghent at 1 site in Belgium.
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 4 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 1 Sep 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 Belgium. 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?
Hearing related quality of life questionnaire (time frame: Once during the baseline testing and once during the post testing (+/- 7 to 8 weeks after the baseline).). The study lists 6 primary outcomes in all. 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 1 Sep 2026.