NCT02331017

Brief Summary

To evaluate the combination of electric hearing through Cochlear Implant and acoustic hearing through hearing aid in bimodal users with moderate-to-severe hearing loss in the non-implanted ear. The research will also provide pilot study data on unilateral Cochlear Implant recipients with residual useful acoustic hearing in the implanted ear whose acoustic hearing has been preserved.

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
20

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
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

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

January 5, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

December 24, 2014

Last Update Submit

January 2, 2015

Conditions

Deafness

Keywords

BimodalCochlear ImplantHearing aidAuditory Perception

Outcome Measures

Primary Outcomes (1)

  • Speech perception task specific tests using assessment protocol which will include 6 speech perception tests in quiet and noise listening conditions.

    ests designed to examine the contribution of bilateral-binaural benefits: 1. Semantically unpredictable sentence recognition presented from the front in the presence of a two-male-talker masker. 2. Horizontal right/left speech lateralization in quiet 3. Perception of monosyllabic words (HAB) in competing three-male-talker babble. 4. Semantically unpredictable sentence recognition in the presence of one competing talker using a reversed speech sentence spoken by only two different talkers with different F0 characteristics. 5. Perception of intonation. 6. Evaluation of the difference between the perception of natural prosody speech and the perception of speech with flattened F0 contour

    12 months

Secondary Outcomes (2)

  • Assessment of functional performance in daily life using self-repot questionnaires

    12 months

  • Standard basic speech perception tests

    12 Months

Study Arms (1)

Bimodal users

EXPERIMENTAL

Bilateral-bimodal users with moderate-to-severe hearing loss who use hearing aids for at least 75% of their waking hours. Administration of Speech perception tests and self-rating questionnaire

Behavioral: Speech perception tests and self-rating questionnaire

Interventions

Speech perception tests and self-rating questionnaireBEHAVIORAL

Speech perception test results and self-rating questionnaire scores will be analyzed by means of non-parametric statistical tests. The statistical tests will be chosen in accordance with the number and type of variables in each test. Correlation between audiological variables (aided and unaided hearing thresholds in the non implanted ear, aided speech perception abilities in the HA-alone condition) and the bilateral-bimodal benefit will be examined. Moreover, possible relationship between self-rating questionnaire scores and speech perception test results will be assessed.

Bimodal users

Eligibility Criteria

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

You may qualify if:

  • Bilateral-bimodal users
  • With moderate-to-severe hearing loss at 250 Hz, 500 Hz and 1000 Hz in the non-implanted ear
  • Who use hearing aids for at least 75% of their waking hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michal Luntz, MD

    Bnai Zion Medica Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Luntz, MD

CONTACT

97248359544michal.luntz@b-zion.org.il

Noam Yehudai, MD

CONTACT

97248359544noam.yehudai@b-zion.org.il

Study Design

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

Study Record Dates

First Submitted

December 24, 2014

First Posted

January 5, 2015

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

January 5, 2015

Record last verified: 2015-01

Locations

IL(1)