Cochlear Implant PDA Based Research Platform (ciPDA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by The University of Texas at Dallas.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Philip Loizou, The University of Texas at Dallas
ClinicalTrials.gov Identifier:
NCT01620385
First received: September 8, 2011
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Hearing Impaired
Device: ciPDA
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multi Center Clinical Study to Assess the Safety of the UTD Cochlear Implant PDA (ciPDA) REsearch Platform

Resource links provided by NLM:


Further study details as provided by The University of Texas at Dallas:

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. [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ciPDA Device: ciPDA
The ciPDA Research Platform device was designed as a research tool for cochlear implant research.
Other Name: Single arm study.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620385

Contacts
Contact: Philip Loizou, PhD 972-883-4617 loizou@utdallas.edu

Locations
United States, Texas
University of Texas - Dallas Recruiting
Richardson, Texas, United States, 75083
Sponsors and Collaborators
Philip Loizou
Investigators
Principal Investigator: Philip Loizou, PhD The University of Texas at Dallas
  More Information

No publications provided

Responsible Party: Philip Loizou, PI, The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT01620385     History of Changes
Other Study ID Numbers: ciPDA0001
Study First Received: September 8, 2011
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas at Dallas:
Cochlear implants

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014