Evaluation of a Binaural Beamformer (StereoZoom) in a Virtual Acoustic Environment and in Real Life

November 28, 2017 updated by: Advanced Bionics AG
The goal of the study is to determine the benefit in speech intelligibility of the BBF and the MBF compared to an omni-directional microphone in different noise conditions. Secondary objective is to determine if there is a subjective preference for one of the microphone settings in different noise conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study participants will be invited for two appointments. In the first appointment test will be performed inside the lab (lab measurements) and outside the lab (real life measurements) and in the second appointment test will be performed in the lab. In between appointments participants are asked to try the Naida CI Q90 at home and in their familiar surroundings for 2-4 weeks (home trial).

Lab measurements:

The Oldenburg Sentence Test (Wagner et al. 2006) will be used as speech signal to determine the speech reception threshold (SRT) for each background noise with an adaptive procedure. The overall level of the noise will be held constant while the level of the speech signal will be adapted depending on the words understood correctly for each sentence.

In addition to the objective speech intelligibility measurements the three microphone settings will also be assessed subjectively. For each background noise scenario the Oldenburg sentences will be presented successively from the frontal loudspeaker. The experimenter will switch between two programs on the participant's processor who then compares the two different microphone settings of these programs. Three paired comparisons will be performed: omni-directional vs. MBF, omni-directional vs. BBF and MBF vs. BBF. The comparisons will be made with regards to speech intelligibility, noise suppression and overall preference in each situation.

Real life measurements:

Even though the results obtained in the lab present a good approximation to real-life performance both beam former options should also be tested outside the lab and in everyday life. In a guided tour the experimenter will take the study participant to noisy places in Zürich, if possible to the same or similar places in which the lab recordings were made. The same paired comparisons as in the lab will be performed with the experimenter talking to the participant or reading a story aloud.

Home trial:

Finally, the study participant should evaluate all three microphone settings for 2-4 weeks during activities in their familiar surroundings, i.e. having a conversation with one or more persons at home, in the tram, in a restaurant, attending a meeting at work, etc. Subjective feedback will be collected in a questionnaire.

Instead of collecting subjective feedback in paper form the questions can be presented on a SmartPhone (Motorola Moto G) screen for those participants able to use a SmartPhone (Motorola Moto G). In that way the participant can answer the questions when he finds himself in a certain listening situation. Such a solution might be more comfortable than a paper questionnaire for some participants. An App for a mobile questionnaire called MobEval already exists from Phonak and will be used in this study. Participants will receive loaner SmartPhones (Motorola Moto G).

Study Type

Observational

Enrollment (Actual)

4

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
      • Zürich, Switzerland, 8091
        • Universitätsspital Zürich, Klinik für ORL

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

See below

Description

Inclusion Criteria:

  • all participants, which signed the Informed Consent (Appendix Informed Consent Form)
  • severe to profound hearing impairment - bilaterally implanted with either the CII or HiRes90k cochlear implant devices
  • experience with their more recent CI at least three months
  • usage of the Naida CI sound processor on each ear for at least three months
  • ability for speech understanding in the presence of competing noise without any assistance from lip-reading
  • score: at least 20% correct for a sentence test delivered with an SNR of +10 dB, or an SRT of better (lower) than +15 dB
  • ability to give subjective feedback in a certain listening situation
  • first language: German or Swiss-German
  • if participants are recruited additionally from other clinics, ability to travel to Zurich

Exclusion Criteria:

  • Acute inflammation or pain in head-/neck area
  • Dizziness
  • Age of participants <18 years
  • Age of participants > 80 years
  • Any participant who is found to require substantial changes to their standard clinical program may be either excluded, or be asked to first get used to the new program before returning for the study test session.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
speech reception thresholds (SRT) assessment with audiological measures
Time Frame: 10 months
The primary study outcome are speech reception thresholds (SRT) measured with three microphone settings
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
paired comparisons assessment with scaling
Time Frame: 10 months
The main secondary outcome are paired comparisons which will be performed in the lab and on a guided tour outside the lab. The comparisons will be made with regards to speech intelligibility, noise suppression and overall preference in each situation.
10 months

Collaborators and Investigators

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

Sponsor

Advanced Bionics AG

Investigators

  • Principal Investigator: Norbert Dillier, Prof. Dr, Universitätsspital Zürich, Klinik für ORL

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)

September 1, 2015

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABERC-14-09-01

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.

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