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Hearing-ImpairmentNCT03005912

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

A study testing Conventional acoustic telephony, Conventional bluetooth telephony and VoIP acoustic telephony in people with Hearing-Impairment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing-Impairment
What is being tested?
Conventional acoustic telephony, Conventional bluetooth telephony and VoIP acoustic telephony
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteSwitzerland
Study dates
1 Apr 2017to 11 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Mentally or physically unfit to participate
  • Vulnerable Person

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital

    Bern, 3010

Other trials in Switzerland

About this study

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.

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

Read the 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).

Being tested
Conventional acoustic telephony, Conventional bluetooth telephony, VoIP acoustic telephony, VoIP bluetooth telephony
Keywords
Speech Comprehension, Telephony, VoIP
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional acoustic telephonyDevice

    Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.

  • Conventional bluetooth telephonyDevice

    Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.

  • VoIP acoustic telephonyDevice

    Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.

  • VoIP bluetooth telephonyDevice

    Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.

Study groups in NCT03005912
Study groupRoleWhat they receive
Conventional acoustic telephonyPlacebo comparatorTelephone 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.
Receives: Device: Conventional acoustic telephony
Conventional bluetooth telephonyActive comparatorTelephone 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.
Receives: Device: Conventional bluetooth telephony
VoIP acoustic telephonyActive comparatorTelephone 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.
Receives: Device: VoIP acoustic telephony
VoIP bluetooth telephonyActive comparatorTelephone 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.
Receives: Device: VoIP bluetooth telephony

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (1)
  1. Subjective perception of speech sound quality

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2016 (estimated)
  2. Study start1 Apr 2017
  3. Primary completion11 May 2018
  4. Study completion11 May 2018

Why it stopped: Insufficient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03005912
Sponsor's protocol ID
Bluetooth-Study
Other IDs
2016-01935, 2016
Status last verified
May 2018
First submitted
26 Jun 2016
Last updated
21 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tyler RS, Baker LJ, Armstrong-Bednall G. Difficulties experienced by hearing-aid candidates and hearing-aid users. Br J Audiol. 1983 Aug;17(3):191-201. doi: 10.3109/03005368309107884.

    PubMed 6357328
  • Cray JW, Allen RL, Stuart A, Hudson S, Layman E, Givens GD. An investigation of telephone use among cochlear implant recipients. Am J Audiol. 2004 Dec;13(2):200-12. doi: 10.1044/1059-0889(2004/025).

    PubMed 15903146
  • Ito J, Nakatake M, Fujita S. Hearing ability by telephone of patients with cochlear implants. Otolaryngol Head Neck Surg. 1999 Dec;121(6):802-4. doi: 10.1053/hn.1999.v121.a93864.

    PubMed 10580241
  • Liu C, Fu QJ, Narayanan SS. Effect of bandwidth extension to telephone speech recognition in cochlear implant users. J Acoust Soc Am. 2009 Feb;125(2):EL77-83. doi: 10.1121/1.3062145.

    PubMed 19206836
  • Horng MJ, Chen HC, Hsu CJ, Fu QJ. Telephone speech perception by Mandarin-speaking cochlear implantees. Ear Hear. 2007 Apr;28(2 Suppl):66S-69S. doi: 10.1097/AUD.0b013e31803153bd.

    PubMed 17496651
  • Fu QJ, Galvin JJ 3rd. Recognition of simulated telephone speech by cochlear implant users. Am J Audiol. 2006 Dec;15(2):127-32. doi: 10.1044/1059-0889(2006/016).

    PubMed 17182877
  • Milchard AJ, Cullington HE. An investigation into the effect of limiting the frequency bandwidth of speech on speech recognition in adult cochlear implant users. Int J Audiol. 2004 Jun;43(6):356-62. doi: 10.1080/14992020400050045.

    PubMed 15457818
  • Kepler LJ, Terry M, Sweetman RH. Telephone usage in the hearing-impaired population. Ear Hear. 1992 Oct;13(5):311-9. doi: 10.1097/00003446-199210000-00009.

    PubMed 1487091
  • Rumeau C, Frere J, Montaut-Verient B, Lion A, Gauchard G, Parietti-Winkler C. Quality of life and audiologic performance through the ability to phone of cochlear implant users. Eur Arch Otorhinolaryngol. 2015 Dec;272(12):3685-92. doi: 10.1007/s00405-014-3448-x. Epub 2014 Dec 20.

    PubMed 25527411
  • Cacciatore F, Napoli C, Abete P, Marciano E, Triassi M, Rengo F. Quality of life determinants and hearing function in an elderly population: Osservatorio Geriatrico Campano Study Group. Gerontology. 1999 Nov-Dec;45(6):323-8. doi: 10.1159/000022113.

    PubMed 10559650
  • Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, Nondahl DM. The impact of hearing loss on quality of life in older adults. Gerontologist. 2003 Oct;43(5):661-8. doi: 10.1093/geront/43.5.661.

    PubMed 14570962
  • Gates GA, Cobb JL, Linn RT, Rees T, Wolf PA, D'Agostino RB. Central auditory dysfunction, cognitive dysfunction, and dementia in older people. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):161-7. doi: 10.1001/archotol.1996.01890140047010.

    PubMed 8630210
  • Barnett S, Franks P. Deafness and mortality: analyses of linked data from the National Health Interview Survey and National Death Index. Public Health Rep. 1999 Jul-Aug;114(4):330-6. doi: 10.1093/phr/114.4.330.

    PubMed 10501133
  • Mantokoudis G, Kompis M, Dubach P, Caversaccio M, Senn P. How internet telephony could improve communication for hearing-impaired individuals. Otol Neurotol. 2010 Sep;31(7):1014-21. doi: 10.1097/MAO.0b013e3181ec1d46.

    PubMed 20634771
  • Mantokoudis G, Dubach P, Pfiffner F, Kompis M, Caversaccio M, Senn P. Speech perception benefits of internet versus conventional telephony for hearing-impaired individuals. J Med Internet Res. 2012 Jul 16;14(4):e102. doi: 10.2196/jmir.1818.

    PubMed 22805169

Questions about this trial

What is this clinical trial studying?

A study testing Conventional acoustic telephony, Conventional bluetooth telephony and VoIP acoustic telephony in people with Hearing-Impairment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech comprehension scores (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03005912, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018; AzTrials last refreshed its copy on 2 Nov 2026.

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