在临床环境中，使用用户操作或传统听力计的听力图比较助听器适配效果：一项盲法非劣效性随机对照试验的研究方案。

Comparison of hearing aid fitting effectiveness with audiograms from either user-operated or traditional audiometry in a clinical setting: a study protocol for a blinded non-inferiority randomised controlled trial.

机构信息

Research Unit for ORL - Head & Neck Surgery and Audiology, University of Southern Denmark, Odense, Denmark

OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark.

出版信息

BMJ Open. 2023 Mar 2;13(3):e065777. doi: 10.1136/bmjopen-2022-065777.

DOI:10.1136/bmjopen-2022-065777

PMID:36863737

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9990669/

Abstract

INTRODUCTION

There is a worldwide need to enhance the capacity of audiometry testing. The objective of this study is to compare the User-operated Audiometry (UAud) system with traditional audiometry in a clinical setting, by investigating if hearing aid effectiveness based on UAud is non-inferior to hearing aid effectiveness based on traditional audiometry, and whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.

METHODS AND ANALYSIS

The design will be a blinded non-inferiority randomised controlled trial. 250 adults referred for hearing aid treatment will be enrolled in the study. Study participants will be tested using both traditional audiometry as well as the UAud system and they will answer the questionnaire Speech, Spatial and Qualities of Hearing Scale (SSQ12) at baseline. Participants will be randomly divided to receive hearing aids fitted based on either UAud or traditional audiometry. Three months after participants have started using their hearing aids, they will undergo a hearing in noise test with hearing aids to measure their speech-in-noise performance and answer the following questionnaires: SSQ12, the Abbreviated Profile of Hearing Aid Benefit and the International Outcome Inventory for Hearing Aids. The primary outcome is a comparison of the change in SSQ12 scores from baseline to follow-up between the two groups. Participants will undergo the user-operated ACT test of spectro-temporal modulation sensitivity as part of the UAud system. The ACT results will be compared with measures of speech intelligibility from the traditional audiometry session and follow-up measurements.

ETHICS AND DISSEMINATION

The project was evaluated by the Research Ethics Committee of Southern Denmark and judged not to need approval. The findings will be submitted to an international peer-reviewed journal and presented at national and international conferences.

TRIAL REGISTRATION NUMBER

NCT05043207.

摘要

简介

在全球范围内都需要提高听力测试的能力。本研究的目的是通过调查基于用户操作的听力测试（UAud）的助听器效果是否不劣于基于传统听力测试的助听器效果，以及用户操作版本的可听对比度阈值（ACT）测试获得的阈值是否与传统言语可懂度测量相关，来比较 UAud 系统与临床环境中的传统听力测试。

方法和分析

设计将是一项盲法非劣效性随机对照试验。将招募 250 名因听力障碍而接受助听器治疗的成年人参加该研究。研究参与者将同时接受传统听力测试和 UAud 系统测试，并在基线时回答言语、空间和听力质量量表（SSQ12）问卷。参与者将被随机分为根据 UAud 或传统听力测试来适配助听器。参与者在开始使用助听器 3 个月后，将在有噪声的情况下使用助听器进行听力测试，以测量他们的言语噪声性能，并回答以下问卷：SSQ12、助听器简明受益问卷和国际助听器结果问卷。主要结果是比较两组从基线到随访时 SSQ12 评分的变化。参与者将接受 UAud 系统中的用户操作 ACT 测试，以测试频谱时间调制敏感性。ACT 结果将与传统听力测试会话和随访测量的言语可懂度测量值进行比较。