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Clinical Trials/NCT03005912
NCT03005912TerminatedNot Applicable

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 Bern1 site in 1 country10 target enrollmentStarted: April 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
10
Locations
1
Primary Endpoint
Speech comprehension scores

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Mentally or physically unfit to participate
  • Vulnerable Person

Arms & Interventions

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.

Intervention: 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.

Intervention: 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.

Intervention: VoIP bluetooth telephony (Device)

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.

Intervention: Conventional acoustic telephony (Device)

Outcomes

Primary Outcomes

Speech comprehension scores

Time Frame: 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.

Secondary Outcomes

  • Subjective perception of speech sound quality(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Markus Huth

Oberarzt

Insel Gruppe AG, University Hospital Bern

Study Sites (1)

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