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Cochlear Implant PDA Based Research Platform (ciPDA)

Primary Purpose

Hearing Impaired

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ciPDA

About this trial

This is an interventional diagnostic trial for Hearing Impaired focused on measuring Cochlear implants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Post-lingually deafened adults:
- 18 years of age or older
- Unilateral or bilateral Nucleus implant users (this includes all three generations of the Nucleus system, i.e., CI22, CI24 and CI24R).
- With or without residual hearing in the contralateral ear. Subjects may use amplification (hearing aid) in the opposite or same ear as the implant.
- A minimum test score of 30% in tape-recorded open-set sentence recognition scores (e.g., spondee identification).
- Minimum of 6 months experience with their implant device. This is done to ensure that all patients are familiar with the hearing sensations perceived by a cochlear implant.
- Minimum number of active electrodes: 10
- Minimum number of subjects for each test site: 5
Prelingually and perilingually deafened adults:
- 18 years of age or older
- Unilateral or bilateral Nucleus implant users.
- With or without residual hearing in the contralateral ear. Subjects may use amplification (hearing aid) in the opposite or same ear as the implant.
- A minimum test score of 10% in tape-recorded open-set sentence recognition scores (e.g., spondee identification).
- Minimum of 6 months experience with their implant device. This is done to ensure that all patients are familiar with the hearing sensations perceived by a cochlear implant.
- Minimum number of active electrodes: 10
- Minimum number of subjects for each test site: 5

Exclusion Criteria:

Non-English speaking
Hearing loss of neural or central origin
Absence of cochlear or VIII nerve development
The presence of systemic condition which would preclude use of a cochlear implant
Active middle ear infection/tympanic membrane perforation
Significantly abnormal cognitive function, as determined by case history information and/or clinical observations
Significant psychiatric disorder, as determined by case history information and/or clinical observations

Sites / Locations

University of Texas - DallasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ciPDA

Arm Description

Outcomes

Primary Outcome Measures

The objective of this study is to assess the safety of the PDA device after long-term use. Safety shall be measured by the adverse events reported in this study and compared to the study results reported in the clinical study for the PMA'd device.

Secondary Outcome Measures

Full Information

NCT ID

NCT01620385

First Posted

September 8, 2011

Last Updated

June 12, 2012

Sponsor

Philip Loizou

1. Study Identification

Unique Protocol Identification Number

NCT01620385

Brief Title

Cochlear Implant PDA Based Research Platform

Acronym

ciPDA

Official Title

Multi Center Clinical Study to Assess the Safety of the UTD Cochlear Implant PDA (ciPDA) REsearch Platform

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Philip Loizou

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary purpose of the research is to study how individuals who wear cochlear implants process sounds in noisy environments and also whether newly designed programs can help improve the communicative ability of cochlear implant patients in noisy situations.

Detailed Description

Cochlear implants have been successful in restoring partial hearing to profoundly deaf people. Despite their success, most implant patients are not able to communicate in noisy environments (e.g., in a restaurant). Communicating in noise still remains one of the biggest challenges in cochlear implants. Little is known about the factors that contribute to the poor performance of CI users in noise. In this project, we propose a series of experiments aimed at isolating these factors. We propose new programs that can be tailored for noisy situations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Impaired

Keywords

Cochlear implants

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ciPDA

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

ciPDA

Other Intervention Name(s)

Single arm study.

Intervention Description

The ciPDA Research Platform device was designed as a research tool for cochlear implant research.

Primary Outcome Measure Information:

Title

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Post-lingually deafened adults: 18 years of age or older Unilateral or bilateral Nucleus implant users (this includes all three generations of the Nucleus system, i.e., CI22, CI24 and CI24R). With or without residual hearing in the contralateral ear. Subjects may use amplification (hearing aid) in the opposite or same ear as the implant. A minimum test score of 30% in tape-recorded open-set sentence recognition scores (e.g., spondee identification). Minimum of 6 months experience with their implant device. This is done to ensure that all patients are familiar with the hearing sensations perceived by a cochlear implant. Minimum number of active electrodes: 10 Minimum number of subjects for each test site: 5 Prelingually and perilingually deafened adults: 18 years of age or older Unilateral or bilateral Nucleus implant users. With or without residual hearing in the contralateral ear. Subjects may use amplification (hearing aid) in the opposite or same ear as the implant. A minimum test score of 10% in tape-recorded open-set sentence recognition scores (e.g., spondee identification). Minimum of 6 months experience with their implant device. This is done to ensure that all patients are familiar with the hearing sensations perceived by a cochlear implant. Minimum number of active electrodes: 10 Minimum number of subjects for each test site: 5 Exclusion Criteria: Non-English speaking Hearing loss of neural or central origin Absence of cochlear or VIII nerve development The presence of systemic condition which would preclude use of a cochlear implant Active middle ear infection/tympanic membrane perforation Significantly abnormal cognitive function, as determined by case history information and/or clinical observations Significant psychiatric disorder, as determined by case history information and/or clinical observations

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Philip Loizou, PhD

Phone

972-883-4617

loizou@utdallas.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip Loizou, PhD

Organizational Affiliation

The University of Texas at Dallas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas - Dallas

City

Richardson

State/Province

Texas

ZIP/Postal Code

75083

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

Cochlear Implant PDA Based Research Platform

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