Communication Training in Hearing Aid Users

NCT07798453 — Not applicable, Completed, 57 participants, University Ghent

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Registry	NCT07798453
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	57 (Actual)
Sponsor	University Ghent (Other); collaborators: Sonova AG
Conditions	Hearing Loss, Age-Related, Hearing Aids, Sensorineural Hearing Loss, Speech Intelligibility, Quality of Life Outcomes
Interventions	Cognitive screening, Audiological Assessment, Questionnaires, Communication training, Interview (Behavioral, other)
Dates	start 2025-09-16, primary completion 2026-07-09, completion 2026-07-09, first posted 2026-09-01, last updated 2026-09-01
Locations	1 site in Belgium

-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. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Control group	Other	Behavioral: Cognitive screening; Behavioral: Audiological Assessment; Behavioral: Questionnaires; Behavioral: Communication training; Other: Interview	The 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: Interview	The individuals receive individual training.
Group with group communication training	Experimental	Behavioral: Cognitive screening; Behavioral: Audiological Assessment; Behavioral: Questionnaires; Behavioral: Communication training; Other: Interview	The individuals receive group training.

Cognitive screening (Behavioral): The Dutch Montreal Cognitive Assessment will be assessed.
Audiological Assessment (Behavioral): 1. Tympanometry 2. Otoscopy 3. Pure-tone audiometry 4. Speech audiometry in quiet and in noise
Questionnaires (Behavioral): 5 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)
Communication training (Behavioral): 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.
Interview (Other): 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.

+Outcome measures

Primary outcomes

Hearing related quality of life questionnaire [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 [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 [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 [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 [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 [This outcome measure will be assessed once: once during the post testing (+/- 7 to 8 weeks after the baseline).]

+Eligibility

Sex: All, ages: 45 Years to 80 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Ghent University Hospital	Ghent, East-Flanders	Belgium

+Investigators

Hannah Keppler, Prof. dr., Principal investigator, University Ghent