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Telephone vs. Voice Over IP Speech Comprehension in Hearing Aided Subjects.

Primary Purpose

Hearing-Impairment

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Conventional acoustic telephony
Conventional bluetooth telephony
VoIP acoustic telephony
VoIP bluetooth telephony
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hearing-Impairment focused on measuring Speech Comprehension, Telephony, VoIP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Conventional acoustic telephony

Conventional bluetooth telephony

VoIP acoustic telephony

VoIP bluetooth telephony

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Speech comprehension scores
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 Outcome Measures

Subjective perception of speech sound quality
Subjective perception of speech sound quality by means of the Mean Opinion Score (MOS).

Full Information

First Posted
June 26, 2016
Last Updated
May 16, 2018
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Cochlear, Stiftung Besser Hören
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1. Study Identification

Unique Protocol Identification Number
NCT03005912
Brief Title
Telephone vs. Voice Over IP Speech Comprehension in Hearing Aided Subjects.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
May 11, 2018 (Actual)
Study Completion Date
May 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Cochlear, Stiftung Besser Hören

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. Bluetooth connection is a well-established wireless technology transmitting at 2.4 gigahertz at distances up to approximately seven meters. The wireless technology is the same for most of bluetooth and Wireless Local Area Network (WLAN) devices. According to the Swiss federal health office the electromagnetic radiation of the bluetooth device as intended to be used in the proposed study fulfils the requirements of the European Committee for Electrotechnical Standardization (CENELEC). Several previous studies demonstrated a significantly increased conventional telephone speech perception with the Cochlear Wireless Phone Clip than without this device. On the other hand, speech perception in hearing impaired people using internet telephony is improved compared to conventional telephony. However, speech perception using the phone clip in connection to internet telephony has not been studied to this date and remains unknown. The purpose of the proposed study is to quantify VoIP vs. conventional telephone speech comprehension in individuals with or without application of bluetooth phone clip. Potentially better speech comprehension due to the application of the phone clip could alleviate the handicap of communication in individuals with hearing aids. As a consequence the social life and contacts of the affected individuals such as worsening of mental state and dependency in the everyday life could be ameliorated only by using a simple device. The goal of this study is to measure speech comprehension of individuals with hearing aids using a bluetooth paired phone clip and VoIP telephony. To quantify a potential benefit of this, speech comprehension has to be tested with and without the phone clip for VoIP and conventional telephony in the same individuals. Speech comprehension will be quantified with a signal/noise ratio of the HSM- sentence test (Hochmair, Schulz, Moser) Upon agreement to participate, patients are invited to the audiological department at Inselspital in Bern. After remaining questions are clarified, the patient has to sign a written informed consent. The investigation will take approximately two hours and takes place in the sound-proof hearing test chambers of the audiological department. Four different speech comprehension scenarios are tested: Conventional telephony without bluetooth device Conventional telephony with bluetooth device VoIP telephony without bluetooth device VoIP telephony with bluetooth device To evaluate speech comprehension, the HSM (Hochmair-Schulz-Moser) sentence test is used. This is a test mainly applied to evaluate the speech comprehension in patients with cochlear implants and consists of 30 lists each including 20 short sentences. After initial presentation of exercise sentences without background noise, additional noise is added while the speech signal is kept at a constant volume level. The percentage of speech comprehension is determined by the quantity of correctly understood sentences at a certain signal-to-noise ratio (S/N Ratio). In this study a S/N Ratio of 10dB, with a signal at 70dB and noise at 60dB, will be analysed. For representativeness of speech comprehension results, participants will use their hearing aids with their daily use volume settings. The phone clip will be programmed for a 1:1 transmission of the telephone conversation and the ambient noise. At the end, the patient has to evaluate the subjective perception of the speech sound quality by means of the Mean Opinion Score (MOS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing-Impairment
Keywords
Speech Comprehension, Telephony, VoIP

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional acoustic telephony
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Conventional bluetooth telephony
Arm Type
Active Comparator
Arm Description
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.
Arm Title
VoIP acoustic telephony
Arm Type
Active Comparator
Arm Description
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.
Arm Title
VoIP bluetooth telephony
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Conventional acoustic telephony
Intervention Description
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Intervention Type
Device
Intervention Name(s)
Conventional bluetooth telephony
Intervention Description
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Intervention Type
Device
Intervention Name(s)
VoIP acoustic telephony
Intervention Description
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Intervention Type
Device
Intervention Name(s)
VoIP bluetooth telephony
Intervention Description
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Primary Outcome Measure Information:
Title
Speech comprehension scores
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Subjective perception of speech sound quality
Description
Subjective perception of speech sound quality by means of the Mean Opinion Score (MOS).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Mantokoudis, MD
Organizational Affiliation
Attending physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
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Telephone vs. Voice Over IP Speech Comprehension in Hearing Aided Subjects.

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