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临床试验/NCT03005912
NCT03005912终止不适用

Clinical Single Centre Cohort Study Comparing Telephone vs. Voice Over Internet Protocol (VoIP) Speech Comprehension for Acoustical and Bluetooth Speech Signal Transmission in Hearing Aided Subjects.

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
2
主要终点
Speech comprehension scores

研究概览

简要总结

Despite modern hearing aids such as cochlear implants, speech comprehension during telephone conversation is challenging for hearing-impaired patients. On the one hand, conventional telephones transmit a limited spectrum of the acoustic signal compared to a normal conversation. On the other hand, lip reading during a phone call is generally not possible. As a result, speech comprehension during a telephone conversation is reduced. In previous studies, the authors demonstrated an improved speech comprehension for hearing-impaired patients using voice-over internet protocol (VoIP) telephony (Skype) compared to conventional telephony.

New bluetooth-enabled hearing aids allow for direct transmission of the telephone signal to the hearing device. As the direct transmission is expected to improve signal-to-noise ratio, speech comprehension is tested in patients with bluetooth-enabled hearing aids for 4 different scenarios: 1. conventional telephony without bluetooth device 2. conventional telephony with bluetooth device 3. VoIP telephony without bluetooth device 4. VoIP telephony with bluetooth device

详细描述

Speech comprehension of hearing impaired individuals is limited in telephone conversations due to the limited acoustic spectrum transmitted by conventional analogue telephones, such as background noise, interferences with the hearing aid and the absent possibility of lip-reading. This can provide an impact on quality of life as better speech comprehension reduces exclusion from social interactions as well as potential professional occupations. Furthermore, in elderly population an impaired hearing function is associated with a higher risk of dementia, mortality rate and dependency in the daily activities.

Mantokoudis et al. recently demonstrated that the larger acoustic spectrum of internet telephony (Voice over Internet Protocol [VoIP]) results in superior speech comprehension of individuals with hearing aids compared to conventional telephones. Low signal quality during internet telephony does not significantly attenuate speech understanding. Another study revealed that internet telephony combined with a webcam further improves speech comprehension as additional lip reading was possible.

New bluetooth audio streaming devices allow for pairing with smart phones or other devices supporting bluetooth technology such as computers for direct routing of the audio signal to the hearing aid. Current state of research shows significant benefits for hearing impaired individuals using this technology for telephone conversations. The speech comprehension and subjective satisfaction can be improved due to a better sound quality and accuracy and less noise interference.

However, speech comprehension of these new bluetooth devices has not been investigated in combination with internet telephony (VoIP) and it remains unclear whether hearing impaired individuals could benefit of this possibility. This study investigates, whether bluetooth audio streaming devices paired to hearing aids/implants combined with internet telephony improves speech comprehension in hearing impaired individuals.

VoIP and conventional telephone speech comprehension will be compared with and without a wireless bluetooth phone clip (Cochlear Wireless Phone Clip, Cochlear Ltd., 1 University Avenue, Macquarie University, New South Wales 2109, Australia). The phone clip is capable to directly connect to other bluetooth-enabled devices and transmits the audio signal directly to the sound processor of the hearing implant. A microphone in the phone clip enables to record and transmit the user's spoken words to the mobile phone therefore a hands-free use is possible.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Bluetooth enabled hearing aid (Nucleus 6 CI or a GN Resound hearing aid) compatible to the phone clip
  • Use of hearing aid for ≥ 3 months.
  • Native German speaker

排除标准

  • Mentally or physically unfit to participate
  • Vulnerable Person

研究组 & 干预措施

Conventional acoustic telephony

Placebo Comparator

Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a conventional mobile phone call with acoustic transmission of the speech signal.

干预措施: Conventional acoustic telephony (Device)

Conventional bluetooth telephony

Active Comparator

Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a conventional mobile phone call with direct bluetooth transmission of the speech signal to the cochlear implant or hearing aid.

干预措施: Conventional bluetooth telephony (Device)

VoIP acoustic telephony

Active Comparator

Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a VoIP mobile phone call with acoustic transmission of the speech signal.

干预措施: VoIP acoustic telephony (Device)

VoIP bluetooth telephony

Active Comparator

Telephone speech comprehension in hearing aided patients (Cochlear Implant or GN Resound hearing aid) for a VoIP mobile phone call with direct bluetooth transmission of the speech signal to the cochlear implant or hearing aid.

干预措施: VoIP bluetooth telephony (Device)

结局指标

主要结局

Speech comprehension scores

时间窗: 2 years

Speech comprehension scores of the HSM-sentence test for each patient with and without bluetooth connection will be measured and compared in conventional and internet telephony.

次要结局

  • Subjective perception of speech sound quality(2 years)

研究者

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

Markus Huth

Oberarzt

Insel Gruppe AG, University Hospital Bern

研究点 (2)

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