Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users

Hearing Loss Clinical Trial

Official title:

Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02323932
• Other study ID #: BZ0085
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2014
• Last updated: December 23, 2014
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Bnai Zion Medical Center
• Contact: Michal Luntz, MD
• Phone: 97248359544
• Email: michal.luntz[@]b-zion.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the benefit of bimodal hearing and bilateral cochlear implant hearing in comparison to unilateral cochlear implant hearing in the perception of speech intonation.

Description:

Bilateral hearing which is a fundamental characteristic of normal auditory system provides significant advantages in adverse listening conditions. In cochlear implant users, binaural hearing can be achieved via bilateral cochlear implant (CI/CI) or binaural-bimodal stimulation, i.e. a cochlear implant in one ear and a hearing aid in the other (CI/HA). It is assumed that CI/CI hearing and CI/HA hearing differ with respect to their physiological sources and functional benefit. Although both hearing prosthesis (CI/CI or CI/HA) lack several of the features needed to allow listeners to experience the full binaural advantage conferred by a normal-hearing auditory system it can, however, provide significant advantages over the use of a unilateral hearing prosthesis. Most of the accepted assessment clinical materials are not sensitive enough to evaluate the contribution of binaural hearing rehabilitation via CI/CI or CI/HA hearing for the perception of intonation. In a previous study the perception of intonation was evaluated in 29 adults CI/HA users via a closed-set format design with the same target talker. The results of the study showed small bimodal benefit. The test paradigm was apparently an easy task for the adult listeners and not sensitive enough to show the expected CI/HA bimodal benefit over cochlear implant alone.

The perception of correct intonation identification will be computed for each listener in each of the listening conditions. The amount of change in the fundamental frequency that was required in order to identify a question will be computed for each listener in each of the conditions. ANOVA with repeated measures will be used to assess the differences among the conditions for each group as well as the differences among the groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Bilateral cochlear implant users

• Bilateral-bimodal users who use hearing aids for at least 75% of their waking hours.

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Behavioral:
• Perception of correct intonation identification
The amount of change in the fundamental frequency that was required in order to identify a question

Locations

Country	Name	City	State
Israel	Bnzi Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of change in the fundamental frequency that was required in order to identify a question		12 months	No