| Registry | NCT07756970 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, health services research |
| Enrollment | 42 (Actual) |
| Sponsor | Istanbul Aydın University (Other) |
| Conditions | Hearing in Noise |
| Interventions | ACT method in fitting, Traditional fitting (Diagnostic test) |
| Dates | start 2025-02-13, primary completion 2025-05-02, completion 2025-06-01, first posted 2026-08-11, last updated 2026-08-11 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Hearing in Noise All trials of ACT method in fitting All trials of Traditional fitting
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental Group | Active comparator | Diagnostic Test: ACT method in fitting | 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. |
| Control Group | Active comparator | Diagnostic Test: Traditional fitting | 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. |
Sex: All, ages: 45 Years to 85 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Istanbul Aydın University | Istanbul, Kucukcekmece | Turkey (Türkiye) |