Cochlear Implant PDA Based Research Platform

Hearing Impaired Clinical Trial

— ciPDA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01620385
• Other study ID #: ciPDA0001
• Status: Recruiting
• Phase: Phase 1
• First received: September 8, 2011
• Last updated: June 12, 2012
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2012
• Source: The University of Texas at Dallas
• Contact: Philip Loizou, PhD
• Phone: 972-883-4617
• Email: loizou[@]utdallas.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deafness
• Hearing Impaired
• Hearing Loss

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas - Dallas	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Philip Loizou

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 weeks	Yes