NCT02323932

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

December 15, 2014

Last Update Submit

December 23, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • The amount of change in the fundamental frequency that was required in order to identify a question

    12 months

Study Arms (2)

Bilateral Cochlear implant users

ACTIVE COMPARATOR

The perception of intonation will be assessed through the use of 2 tests. In the first test, listeners will have to identify statements and yes/no questions that will be presented by male and female talkers in the background of four- talkers-babble noise comprised of two females and two males. In the second test, listeners will be presented with gradual changes in the fundamental frequency of a sentence. They will be required to identify the sentence with each of the changes as a statement or a question. Each of the 2 tests will be presented in three listening conditions: each of the CI alone and bilateral (CI/CI) conditions.

Behavioral: Perception of correct intonation identification

Bimodal Cochlear implant users

ACTIVE COMPARATOR

The perception of intonation will be assessed through the use of 2 tests. In the first test, listeners will have to identify statements and yes/no questions that will be presented by male and female talkers in the background of four- talkers-babble noise comprised of two females and two males. In the second test, listeners will be presented with gradual changes in the fundamental frequency of a sentence. They will be required to identify the sentence with each of the changes as a statement or a question. Each of the 2 tests will be presented in three listening conditions: CI alone, HA alone and bimodal (CI/HA) conditions.

Behavioral: Perception of correct intonation identification

Interventions

The amount of change in the fundamental frequency that was required in order to identify a question

Bilateral Cochlear implant usersBimodal Cochlear implant users

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnzi Zion Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michal Luntz, MD

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Otolaryngology Head and Neck Department

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 24, 2014

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

December 24, 2014

Record last verified: 2014-12

Locations