The Hear Clear Study
Hearing Aid Benefit in Adults With Self-Reported Hearing Difficulty Yet Normal Pure-Tone Audiograms (Duke sIRB)
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jenny L Norris, MA
- 전화번호: 919-681-2137
- 이메일: jenny.l.norris@duke.edu
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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연락하다:
- Jenny L Norris, MA
- 전화번호: 919-681-2137
- 이메일: jenny.l.norris@duke.edu
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연락하다:
- Sherri L Smith, Au.D., Ph.D.
- 전화번호: 919-613-1110
- 이메일: sherri.smith@duke.edu
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수석 연구원:
- Sherri L Smith, Au.D., Ph.D.
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Ohio
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Columbus, Ohio, 미국, 43210
- The Ohio State University
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연락하다:
- Christina M Roup, Ph.D.
- 전화번호: 614-247-8614
- 이메일: roup.2@osu.edu
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수석 연구원:
- Christina M Roup, Ph.D.
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Are adults (≥18 years) presenting with "normal hearing" (pure-tone thresholds ≤25 dB HL from 250-4000 Hz) but hearing trouble (≥20 points on RHHI questionnaire)
- Are willing to try amplification (i.e., hearing aids) for the first time
- Can Read/write in American English
- Have access to email, internet, and phone
Exclusion Criteria:
- Participants with self-reported otologic history (e.g., ear surgery, ototoxic medications, middle-ear dysfunction, holes in ear drums)
- Have moderate to severe traumatic brain injury
- Have bothersome tinnitus as their primary complaint
- Have a health condition that would interfere with study participation (e.g., dementia/cognitive disorder, blindness)
- Prior hearing aid use
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Open-dome receiver-in-canal hearing aids
Air-conduction receiver-in-canal (RIC) hearing aids with open domes, which have holes or vents that let natural sound and air pass into the ear canal.
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Participants will be randomly assigned to either the open dome or closed dome group (Factor 1). Participants will then obtain their first treatment arm with a random assignment of either an SNR neutral (SNR-) or SNR enhanced (SNR+) hearing aid fitting (Factor 2). They will return to the lab for testing prior to crossing over to the second arm (the other SNR configuration: SNR- or SNR+). The SNR+ setting contains features to improve the signal-to-noise ratio of the sound to optimize speech over noise through the hearing aids. Participants will be randomly assigned to either the open dome or closed dome group (Factor 1). Participants will then obtain their first treatment arm with a random assignment of either an SNR neutral (SNR-) or SNR enhanced (SNR+) hearing aid fitting (Factor 2). They will return to the lab for unaided baseline testing prior to crossing over to the second arm (the other SNR configuration: SNR- or SNR+). The SNR- setting contains focuses on improving audibility of sounds through the hearing aids. |
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실험적: Closed-dome receiver-in-canal hearing aids
Air-conduction receiver-in-canal (RIC) hearing aids with closed domes, which have solid rubber with tiny or no vents to seal the ear.
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Participants will be randomly assigned to either the open dome or closed dome group (Factor 1). Participants will then obtain their first treatment arm with a random assignment of either an SNR neutral (SNR-) or SNR enhanced (SNR+) hearing aid fitting (Factor 2). They will return to the lab for testing prior to crossing over to the second arm (the other SNR configuration: SNR- or SNR+). The SNR+ setting contains features to improve the signal-to-noise ratio of the sound to optimize speech over noise through the hearing aids. Participants will be randomly assigned to either the open dome or closed dome group (Factor 1). Participants will then obtain their first treatment arm with a random assignment of either an SNR neutral (SNR-) or SNR enhanced (SNR+) hearing aid fitting (Factor 2). They will return to the lab for unaided baseline testing prior to crossing over to the second arm (the other SNR configuration: SNR- or SNR+). The SNR- setting contains focuses on improving audibility of sounds through the hearing aids. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Revised Hearing Handicap Inventory (RHHI)
기간: Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)
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18-item questionnaire that assesses self-perceived hearing difficulty associated with social and emotional situations and is considered a hearing-related quality of life measure.
Higher scores indicate MORE hearing difficulty.
Administered unaided and aided.
Scores range from 0 - 72.
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Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Abbreviated Profile of Hearing Aid Benefit (APHAB)
기간: Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)
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24-item questionnaire used to assess hearing problems in various listening environments (e.g., quiet, background noise, reverberation, and aversiveness to sound).
Higher scores indicate greater hearing problems.
Administered unaided and aided.
Scores range from 1% to 99%.
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Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)
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Words in Noise (WIN) Test
기간: Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)
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35-word recognition in noise test with 5 words at each of the 7 signal-to-noise ratios that go from 24 dB SNR to 0 dB SNR in 4-dB decrements.
The noise (six talker babble) is held constant with the level of the words varying to make up the SNRs.
Listener repeats words in background noise of talkers where the words get progressively softer.
Higher scores indicate more trouble hearing in noise.
Administered unaided and aided.
Scores range from 0dB to 24dB.
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Baseline (unaided), 4 weeks (aided with intervention 1), 4 weeks (after wash-out period, and unaided), and 4 weeks (aided with intervention 2)
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Sherri L Smith, Au.D., Ph.D., Duke University
간행물 및 유용한 링크
일반 간행물
- Roup CM, Post E, Lewis J. Mild-Gain Hearing Aids as a Treatment for Adults with Self-Reported Hearing Difficulties. J Am Acad Audiol. 2018 Jun;29(6):477-494. doi: 10.3766/jaaa.16111.
- Singh J, Doherty KA. Use of a Mild-Gain Hearing Aid by Middle-Age Normal-Hearing Adults Who Do and Do Not Self-Report Trouble Hearing in Background Noise. Am J Audiol. 2020 Sep 3;29(3):419-428. doi: 10.1044/2020_AJA-19-00051. Epub 2020 Jun 30.
- Mealings K, Valderrama JT, Mejia J, Yeend I, Beach EF, Edwards B. Hearing Aids Reduce Self-Perceived Difficulties in Noise for Listeners With Normal Audiograms. Ear Hear. 2024 Jan-Feb 01;45(1):151-163. doi: 10.1097/AUD.0000000000001412. Epub 2023 Aug 9.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
기타 연구 ID 번호
- Pro00120285
- 1R01DC022584-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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