跳至主要内容
临床试验/NCT03897634
NCT03897634已完成不适用

Clinical Trial of Roger Adaptive Digital Technology

Northwestern University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)

研究概览

简要总结

Despite improvements in digital hearing aid technology, many hearing aid users continue to report difficulty understanding speech in challenging listening environments. Remote microphones have been shown to provide benefit in the most common of these challenging listening environments: distant speakers, background noise, and reverberation. Despite demonstrated benefit, there is a low rate of remote microphone use among adult hearing aid users. One reason for low uptake may be an uncertainty among hearing healthcare providers and potential users regarding expected clinically relevant benefit. This clinical trial will attempt the following:

  1. To describe the range of remote microphone benefit among adults with mild-to-moderate sensorineural hearing loss
  2. To determine specific individual factors beyond the audiogram that are associated with greater benefit from remote microphones

详细描述

2.0 Background / Literature Review / Rationale for the study:

Even when wearing well-fit hearing aids, many individuals with hearing loss continue to report difficulty communicating in background noise is one of the most common complaints of individuals with hearing loss. Directional microphones can improve speech perception in noise, but often fail to provide benefit in cases where the talker is distant from the listener, where there are multiple or moving noise sources, or in reverberation. Digital noise reduction may reduce listening effort and improve listening comfort, but has minimal effect on speech perception.

Placing the microphone in close proximity to the talker reduces the effective distance between speaker and listener, compensating for the effects of background noise and reverberation on the target signal. Use of a remote microphone can significantly improve signal-to-noise ratio (SNR), thereby improving speech perception in noise and at a distance. Recent studies demonstrated that remote-microphone devices that utilize adaptive digital technology (i.e, Roger) provide significantly more benefit for speech understanding in noise than non-adaptive remote microphones. Those advantages are likely related to the adaptive nature of the device, whereby the microphone gain varies according to the level of noise in the environment. In addition, interference is reduced via transmission of short digital bursts (160 μs) across a range of channels (2.4-2.4835 GHz). Further, the ability to utilize the hearing aids' onboard directional microphones in conjunction with a remote microphone gives listeners the benefits of remote microphone use without sacrificing nearfield intelligibility. The Roger system has also been shown to improve cell phone communication amongst cochlear implant patients.

Despite demonstrated advantages, use of remote microphone assistive devices among adults is low. In a recent study of listeners with severe hearing loss-a group which has substantial difficulty communicating in background noise, and is likely to receive significant benefits from remote-microphone devices-less than 10% reported use of a remote microphone. While cost may be a barrier for some users, even when such systems are available for free (as in the Veterans Administration), use is still low. One reason may be uncertainty among both providers and potential users as to expected benefit for a given listener. For example, Lewis et al. failed to demonstrate a clinically-significant benefit of remote microphone use using a work-life outcomes scale in a cohort of mostly nonworking (retired) participants. Wolfe et al. found significant improvements in objective speech recognition on average, but with a wide range of benefit (from 10% to 60% improvement across individual participants). That study also suggested that individual factors may affect remote microphone benefit, in that the magnitude of improved recognition was correlated with the ability to use spatial cues to improve recognition.

Research Locations:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults age 18-85 years
  • •Speak English as their primary language
  • •Normal or corrected to normal vision
  • •Sensorineural hearing loss with pure-tone thresholds 20-85 dB HL at octave frequencies between 500 and 3000 Hz
  • •Current hearing aid wearer with at least 3 months of experience

排除标准

  • •Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator places the participant at unacceptable risk if he or she were to participate in the study
  • •Participants who do not pass a cognitive screening test (e.g., MoCA)
  • •Significant history of otologic or neurologic disorders
  • •Conductive hearing loss pathology or fluctuating hearing loss

研究组 & 干预措施

Experiences Hearing Aid user

Experimental

Single arm study, all participants in this arm. Participants will be experienced hearing aid users.

干预措施: Remote Microphone (Device)

结局指标

主要结局

Change in Abbreviated Profile of Hearing Aid Benefit (APHAB)

时间窗: Change from baseline to final appointment will be assessed. Participants will take a baseline at the start of the trial and then complete post-intervention at the end of the 30-day trial.

Self assessment, disability based inventory that is used to document outcomes of hearing aid fittings. The APHAB uses a percentile scale (Percent of Problems). This measure has 4 subscales: Ease of communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). A lower score indicates a better outcome. We will look at both the global change (defined as EC, RV, and BN scores improving by at least 5 points each) and individual subscales (For EC, RV, or BN a change in 22 points is considered significant and for AV a change of 31 points is needed to be considered significant).

次要结局

  • Change in Speech, Spatial, and Qualities of Hearing (SSQ)(Change from baseline to final appointment will be assessed. Participants will take a baseline at the start of the trial and then complete post-intervention at the end of the 30-day trial.)
  • % of Words Repeated Correctly in a Sentence Recognition Task With Variable Levels of Background Noise(End of trial: Objective speech intel was collected in one session at the end of the 30 day trial with the remote microphone. Order of conditions (Hearing aid only and Hearing Aid+ Remote Mic) was randomized.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pamela Souza

Professor

Northwestern University

研究点 (1)

Loading locations...

相似试验