NCT01059838

Brief Summary

The purpose of this study is to determine whether speech recognition in noise can be improved by the addition of a special listening program to the sound processor. Thus we propose to assess speech perception in noise for pediatric cochlear implant patients using both their everyday listening program as well an ASC program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

January 28, 2010

Last Update Submit

September 7, 2017

Conditions

Hearing Loss

Keywords

pediatricscochlear implant

Outcome Measures

Primary Outcomes (1)

  • The Objective is to examine speech perception performance in the presence of restaurant noise for pediatric cochlear implant recipients in two listening conditions: ADRO alone & ASC + ADRO.

    1 year

Study Arms (1)

single subject

EXPERIMENTAL
Behavioral: sentence recognition

Interventions

sentence recognitionBEHAVIORAL

testing the ability for sentence recognition in quiet and in noise.

single subject

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cynthia A Hargenrader, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2010

First Posted

February 1, 2010

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations

US(1)