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

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ClinicalTrials.gov Identifier: NCT03005912
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : December 30, 2016
Last Update Posted : May 21, 2018
Sponsor:
Collaborators:
Cochlear
Stiftung Besser Hören
Information provided by (Responsible Party):
Markus Huth, University Hospital Inselspital, Berne

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


Condition or disease Intervention/treatment Phase
Hearing-Impairment Device: Conventional acoustic telephony Device: Conventional bluetooth telephony Device: VoIP acoustic telephony Device: VoIP bluetooth telephony Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : May 11, 2018
Actual Study Completion Date : May 11, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Subjective perception of speech sound quality [ Time Frame: 2 years ]
    Subjective perception of speech sound quality by means of the Mean Opinion Score (MOS).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005912


Locations
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Switzerland
University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Cochlear
Stiftung Besser Hören
Investigators
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Principal Investigator: Georgios Mantokoudis, MD Attending physician

Publications of Results:
Wolfe J, Morais M, Schafer E. Improving Hearing Performance in Cochlear Nucleus 6 users with true wireless accessories. Cochlear Limited. 2015 May; D710887 ISS2
Robier M, Bakhos D, Pawelczyk T, Lescanne E. Evaluation of benefit provided by the Cochlear Wireless Phone Clip. Cochlear Limited.2015 Dec; D785163 ISS1
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
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
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
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
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

Other Publications:

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Responsible Party: Markus Huth, Oberarzt, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03005912     History of Changes
Other Study ID Numbers: Bluetooth-Study
2016-01935 ( Other Identifier: Kantonale Ethikkommission Bern )
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Markus Huth, University Hospital Inselspital, Berne:
Speech Comprehension
Telephony
VoIP

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms