- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07756970
Speech Perception, Spatial Perception and Satisfaction Outcomes of Fitting Based on Hearing In Noise Ability
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kucukcekmece
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Istanbul, Kucukcekmece, 터키 (Türkiye), 34295
- Istanbul Aydın University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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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.
다른 이름들:
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Eco-HINT
기간: 1 week and 1 month after hearing aid fitting
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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.
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1 week and 1 month after hearing aid fitting
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Speech, Spatial Perception and Hearing Quality Scale
기간: 1 week and 1 month after hearing aid fitting
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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.
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1 week and 1 month after hearing aid fitting
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APHAB survey
기간: 1 week and 1 month after hearing aid fitting
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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".
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1 week and 1 month after hearing aid fitting
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Audible Contrast Threshold (ACT)
기간: Time Frame: 1 week and 1 month after hearing aid fitting
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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.
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Time Frame: 1 week and 1 month after hearing aid fitting
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공동 작업자 및 조사자
수사관
- 연구 책임자: Sule Cekic, associate professor, Ankara Yildirim Beyazıt University
- 연구 책임자: Umıt Can Cetinkaya, assistant professor, Istanbul Aydın University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 61351342/020-385
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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