The Hear Clear Study
Hearing Aid Benefit in Adults With Self-Reported Hearing Difficulty Yet Normal Pure-Tone Audiograms (Duke sIRB)
調査の概要
状態
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jenny L Norris, MA
- 電話番号：919-681-2137
- メール：jenny.l.norris@duke.edu
研究場所
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke University Medical Center
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コンタクト：
- Jenny L Norris, MA
- 電話番号：919-681-2137
- メール：jenny.l.norris@duke.edu
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コンタクト：
- Sherri L Smith, Au.D., Ph.D.
- 電話番号：919-613-1110
- メール：sherri.smith@duke.edu
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主任研究者：
- Sherri L Smith, Au.D., Ph.D.
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Ohio
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Columbus、Ohio、アメリカ、43210
- The Ohio State University
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コンタクト：
- Christina M Roup, Ph.D.
- 電話番号：614-247-8614
- メール：roup.2@osu.edu
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主任研究者：
- Christina M Roup, Ph.D.
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Revised Hearing Handicap Inventory (RHHI)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Abbreviated Profile of Hearing Aid Benefit (APHAB)
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Sherri L Smith, Au.D., Ph.D.、Duke University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Pro00120285
- 1R01DC022584-01A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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