Speech Perception, Spatial Perception and Satisfaction Outcomes of Fitting Based on Hearing In Noise Ability
8 agosto 2026 aggiornato da: Melek Başak ÖZKAN, Istanbul Aydın University
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
42
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Kucukcekmece
-
Istanbul, Kucukcekmece, Turchia (Türkiye), 34295
- Istanbul Aydın University
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Experimental Group
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.
|
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.
Altri nomi:
|
|
Comparatore attivo: Control Group
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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Eco-HINT
Lasso di tempo: 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.
|
1 week and 1 month after hearing aid fitting
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Speech, Spatial Perception and Hearing Quality Scale
Lasso di tempo: 1 week and 1 month after hearing aid fitting
|
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.
|
1 week and 1 month after hearing aid fitting
|
|
APHAB survey
Lasso di tempo: 1 week and 1 month after hearing aid fitting
|
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".
|
1 week and 1 month after hearing aid fitting
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Audible Contrast Threshold (ACT)
Lasso di tempo: Time Frame: 1 week and 1 month after hearing aid fitting
|
The ACT is a suprathreshold, non-language-specific test that measures an individual's ability to hear in real-world noisy environments to determine the level of assistance needed in noise.
ACT values are determined by level of intensity.
A normal ACT value is between -4 and +4 dB nCL. 4 to 7 dB nCL indicates mild loss, 7 to 10 dB nCL indicates moderate loss, and 10 to 16 dB nCL indicates profound loss.
|
Time Frame: 1 week and 1 month after hearing aid fitting
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Sule Cekic, associate professor, Ankara Yildirim Beyazıt University
- Direttore dello studio: Umıt Can Cetinkaya, assistant professor, Istanbul Aydın University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
13 febbraio 2025
Completamento primario (Effettivo)
2 maggio 2025
Completamento dello studio (Effettivo)
1 giugno 2025
Date di iscrizione allo studio
Primo inviato
31 marzo 2025
Primo inviato che soddisfa i criteri di controllo qualità
8 agosto 2026
Primo Inserito (Effettivo)
11 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 agosto 2026
Ultimo verificato
1 marzo 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Comportamento
- Comportamento spaziale
- Orientamento, spaziale
- Fenomeni fisiologici muscoloscheletrici e neurali
- Sanità pubblica
- Ambiente e salute pubblica
- Fenomeni fisiologici
- Fenomeni fisici
- Ambiente
- Fenomeni ecologici e ambientali
- Fenomeni biologici
- Radiazione
- Radiazione, non ionizzante
- Fenomeni fisiologici del sistema nervoso
- Suono
- Sensazione
- Inquinamento ambientale
- Fenomeni fisiologici vestibulocochleari
- Rumore
- Udito
Altri numeri di identificazione dello studio
- 61351342/020-385
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .