NCT03005912

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

June 26, 2016

Last Update Submit

May 16, 2018

Conditions

Keywords

Speech ComprehensionTelephonyVoIP

Outcome Measures

Primary Outcomes (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.

    2 years

Secondary Outcomes (1)

  • Subjective perception of speech sound quality

    2 years

Study Arms (4)

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.

Device: Conventional acoustic telephony

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.

Device: Conventional bluetooth telephony

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.

Device: VoIP acoustic telephony

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.

Device: VoIP bluetooth telephony

Interventions

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

Conventional acoustic telephony

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

Conventional bluetooth telephony

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

VoIP acoustic telephony

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

VoIP bluetooth telephony

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Mentally or physically unfit to participate
  • Vulnerable Person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Bern, 3010, Switzerland

Location

Related Publications (26)

  • 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.

    PMID: 6357328BACKGROUND
  • 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).

    PMID: 15903146BACKGROUND
  • 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.

    PMID: 10580241BACKGROUND
  • 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.

    PMID: 19206836BACKGROUND
  • 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.

    PMID: 17496651BACKGROUND
  • 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).

    PMID: 17182877BACKGROUND
  • 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.

    PMID: 15457818BACKGROUND
  • 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.

    PMID: 1487091BACKGROUND
  • 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.

    PMID: 25527411BACKGROUND
  • 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.

    PMID: 10559650BACKGROUND
  • 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.

    PMID: 14570962BACKGROUND
  • 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.

    PMID: 8630210BACKGROUND
  • 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.

    PMID: 10501133BACKGROUND
  • 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.

  • 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.

  • Mantokoudis G, Dahler C, Dubach P, Kompis M, Caversaccio MD, Senn P. Internet video telephony allows speech reading by deaf individuals and improves speech perception by cochlear implant users. PLoS One. 2013;8(1):e54770. doi: 10.1371/journal.pone.0054770. Epub 2013 Jan 24.

  • Wolfe J, Morais M, Schafer E. Improving Hearing Performance in Cochlear Nucleus 6 users with true wireless accessories. Cochlear Limited. 2015 May; D710887 ISS2

    RESULT
  • Robier M, Bakhos D, Pawelczyk T, Lescanne E. Evaluation of benefit provided by the Cochlear Wireless Phone Clip. Cochlear Limited.2015 Dec; D785163 ISS1

    RESULT
  • Martinez Basterra Z, Fernández de Pinedo M, Altuna Mariexcurrena X. Telephone speech recognition improvement in a noisy environment: use of a Bluetooth accessory. Cochlear Limited.2015 Dec; D785163 ISS1

    RESULT
  • Kim MB, Chung WH, Choi J, Hong SH, Cho YS, Park G, Lee S. Effect of a Bluetooth-implemented hearing aid on speech recognition performance: subjective and objective measurement. Ann Otol Rhinol Laryngol. 2014 Jun;123(6):395-401. doi: 10.1177/0003489414526847.

  • Marcrum SC. Wireless streaming with the Cochlear Wireless Phone Clip improves speech understanding and reduces listening effort during telephone use in noise. Cochlear Limited.2015 Dec; D785163 ISS1

    RESULT
  • Gündüz B, Gökdoğan C, Orçan E, Fikret Çetik M, Tuncer Ü, Özdemiroğlu S. Hearing inventory with the Cochlear Wireless Phone Clip in experienced adult cochlear implant recipients at work and during daily life. Cochlear Limited.2015 Dec; D785163 ISS1

    RESULT
  • Duke M, Wolfe J. Evaluation of speech recognition over the telephone with and without the Cochlear Wireless Phone Clip. Cochlear Limited.2015 Dec; D785163 ISS1

    RESULT
  • Çiprut A, Derinsu U, Cesur S, Çiçek B, Özkan B, Yücel E. Speech intelligibility with the Cochlear Wireless Phone Clip in experienced cochlear implant recipients. Cochlear Limited.2015 Dec; D785163 ISS1

    RESULT
  • Qian H, Loizou PC, Dorman MF. A phone-assistive device based on Bluetooth technology for cochlear implant users. IEEE Trans Neural Syst Rehabil Eng. 2003 Sep;11(3):282-7. doi: 10.1109/TNSRE.2003.816871.

  • Hochmair-Desoyer I, Schulz E, Moser L, Schmidt M. The HSM sentence test as a tool for evaluating the speech understanding in noise of cochlear implant users. Am J Otol. 1997 Nov;18(6 Suppl):S83.

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Georgios Mantokoudis, MD

    Attending physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oberarzt

Study Record Dates

First Submitted

June 26, 2016

First Posted

December 30, 2016

Study Start

April 1, 2017

Primary Completion

May 11, 2018

Study Completion

May 11, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations