A Validation of the UAud System for User-operated Audiometry Testing in a Clinical Setting: A Study Protocol for a Blinded Non-inferiority Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- SSQ12 (Speech, Spatial & Qualities of Hearing scale)
研究概览
简要总结
The objective of this study is to validate the User-operated Audiometry (UAud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on UAud is non-inferior to hearing rehabilitation 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.
详细描述
The project will focus on the initial examination of patients who are referred for hearing aid treatment. This initial examination consists of an audiometry which is currently conducted manually by an audiologist. However, it is possible to conduct an audiometry as a user-operated self-test by using a computer. The project will test if hearing rehabilitation based on the user-operated audiometry is non-inferior to hearing rehabilitation based on the gold standard of manual audiometry. The project will use several types of patient reported measures as well as objective measurements in the clinic. Research of this type is needed to understand if the quality of the hearing aid treatment is equal no matter the type of examination.
Also, the study will investigate whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
The HA fitting procedure will be blinded, so neither the participant, the audiologist, nor the follow up test examiner knows which group the participant belongs to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sensorineural hearing loss with hearing thresholds exceeding 20 dB HL at two or more frequencies in the frequency range of 0.5 to 4 kHz.
- •Symmetric hearing loss with a maximum pure-tone average (PTA) (mean of 0.5-1-2-4 kHz) difference between the ears of 15 dB HL.
- •Danish native speaker.
- •No previous experience with HAs.
- •Capable of answering questionnaires through an online mailbox.
排除标准
- •Air-conduction audiometry thresholds exceeding 80 dB HL at two or more frequencies.
- •Treatment affected by conductive hearing loss (air-bone gap >10 dB on more than one frequency below 1 kHz).
- •Conditions with fluctuating hearing loss, e.g., Menière's, on-going treatment with ototoxic drugs.
- •Ear, nose, or throat surgery in the past 12 months.
- •Evidence that the participant has made minor use of the HAs during the study (e.g., < 2h per day).
- •Visual or motor impairment that might affect the use of the UAud system.
研究组 & 干预措施
uAud
Patients which hearing aid is fitted based on the audiometry obtained with user-operated automated audiometry.
干预措施: uAud (Diagnostic Test)
control
Patients which hearing aid is fitted based on the audiometry obtained with traditional audiometry.
干预措施: Traditional audiometry (Diagnostic Test)
结局指标
主要结局
SSQ12 (Speech, Spatial & Qualities of Hearing scale)
时间窗: 3 months
A questionnaire reflecting the patient's subjective assessment of hearing in everyday life.
次要结局
- HINT (Hearing In Noise Test)(3 months)