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

May 16, 2018 updated by: Markus Huth, University Hospital Inselspital, Berne

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.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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:

  1. Conventional telephony without bluetooth device
  2. Conventional telephony with bluetooth device
  3. VoIP telephony without bluetooth device
  4. 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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Conventional acoustic telephony
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.
Device: Conventional acoustic telephony
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Active Comparator: Conventional bluetooth telephony
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.
Device: Conventional bluetooth telephony
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Active Comparator: VoIP acoustic telephony
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.
Device: VoIP acoustic telephony
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Active Comparator: VoIP bluetooth telephony
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.
Device: VoIP bluetooth telephony
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective perception of speech sound quality
Time Frame: 2 years
Subjective perception of speech sound quality by means of the Mean Opinion Score (MOS).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Cochlear
Stiftung Besser Hören

Investigators

  • Principal Investigator: Georgios Mantokoudis, MD, Attending Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

May 11, 2018

Study Completion (Actual)

May 11, 2018

Study Registration Dates

First Submitted

June 26, 2016

First Submitted That Met QC Criteria

December 26, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 16, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bluetooth-Study
  • 2016-01935 (Other Identifier: Kantonale Ethikkommission Bern)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing-Impairment

Clinical Trials on Conventional acoustic telephony

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe