Study Stopped
Insufficient recruitment
Telephone vs. Voice Over IP Speech Comprehension in Hearing Aided Subjects.
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.
2 other identifiers
interventional
10
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
1 active site
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
CompletedFirst Posted
Study publicly available on registry
December 30, 2016
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2018
CompletedMay 21, 2018
May 1, 2018
1.1 years
June 26, 2016
May 16, 2018
Conditions
Keywords
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 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.
Conventional bluetooth telephony
ACTIVE 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.
VoIP acoustic telephony
ACTIVE 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.
VoIP bluetooth telephony
ACTIVE 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.
Interventions
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
Eligibility Criteria
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
- Insel Gruppe AG, University Hospital Bernlead
- Cochlearcollaborator
- Stiftung Besser Hörencollaborator
Study Sites (1)
University Hospital
Bern, 3010, Switzerland
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: 6357328BACKGROUNDCray 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: 15903146BACKGROUNDIto 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: 10580241BACKGROUNDLiu 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: 19206836BACKGROUNDHorng 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: 17496651BACKGROUNDFu 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: 17182877BACKGROUNDMilchard 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: 15457818BACKGROUNDKepler 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: 1487091BACKGROUNDRumeau 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: 25527411BACKGROUNDCacciatore 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: 10559650BACKGROUNDDalton 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: 14570962BACKGROUNDGates 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: 8630210BACKGROUNDBarnett 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: 10501133BACKGROUNDMantokoudis 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.
PMID: 20634771RESULTMantokoudis 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.
PMID: 22805169RESULTMantokoudis 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.
PMID: 23359119RESULTWolfe J, Morais M, Schafer E. Improving Hearing Performance in Cochlear Nucleus 6 users with true wireless accessories. Cochlear Limited. 2015 May; D710887 ISS2
RESULTRobier M, Bakhos D, Pawelczyk T, Lescanne E. Evaluation of benefit provided by the Cochlear Wireless Phone Clip. Cochlear Limited.2015 Dec; D785163 ISS1
RESULTMartinez 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
RESULTKim 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.
PMID: 24687593RESULTMarcrum 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
RESULTGündüz 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
RESULTDuke M, Wolfe J. Evaluation of speech recognition over the telephone with and without the Cochlear Wireless Phone Clip. Cochlear Limited.2015 Dec; D785163 ISS1
RESULTÇiprut 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
RESULTQian 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.
PMID: 14518792RESULTHochmair-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.
PMID: 9391610RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georgios Mantokoudis, MD
Attending physician
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