NCT02644343

Brief Summary

The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2017

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 10, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

December 28, 2015

Results QC Date

October 18, 2020

Last Update Submit

November 9, 2020

Conditions

Telemedicine

Outcome Measures

Primary Outcomes (1)

  • Speech Perception on Monosyllabic Word Test, CNC Words

    Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test measured by percentage of words correct to examine their speech perception abilities after each remote programming session.

    2-4 weeks post remote programming session

Study Arms (1)

Remote Programming Group

EXPERIMENTAL

Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform. The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.

Device: Custom Sound

Interventions

Custom SoundDEVICE

Custom Sound is the programming software used to program Nucleus cochlear implants.

Remote Programming Group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged greater than 12 years that are native English speakers and are capable of completing the study evaluation as deemed by their primary audiologist
  • Unilateral or bilateral cochlear implant recipients of a CI24RE, CI422 or CI500 series implant who are in possession of a backup sound processor
  • A minimum of 12 months' experience with a CP800 or CP900 series sound processor, and current MAP programmed within 12 months prior to Visit 1
  • Willingness to participate in and to comply with all requirements of the protocol
  • Able to demonstrate protocol competence as confirmed by primary audiologist

You may not qualify if:

  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of remote service delivery
  • Unwillingness or inability of the candidate to comply with all investigational requirements
  • Additional handicaps that would prevent or restrict participation in the audiological evaluations
  • Inability to demonstrate basic technological skills for simple computer-based tasks and device connecting after training by primary audiologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rocky Mountain Ear Center

Englewood, Colorado, 80113, United States

Location

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27713, United States

Location

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (4)

  • Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.

    PMID: 15035561BACKGROUND

  • PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.

    PMID: 14485785BACKGROUND

  • Wesarg T, Wasowski A, Skarzynski H, Ramos A, Falcon Gonzalez JC, Kyriafinis G, Junge F, Novakovich A, Mauch H, Laszig R. Remote fitting in Nucleus cochlear implant recipients. Acta Otolaryngol. 2010 Dec;130(12):1379-88. doi: 10.3109/00016489.2010.492480. Epub 2010 Jun 30.

    PMID: 20586675BACKGROUND

  • McElveen JT Jr, Blackburn EL, Green JD Jr, McLear PW, Thimsen DJ, Wilson BS. Remote programming of cochlear implants: a telecommunications model. Otol Neurotol. 2010 Sep;31(7):1035-40. doi: 10.1097/MAO.0b013e3181d35d87.

    PMID: 20147864BACKGROUND

Results Point of Contact

Title
Cochlear Clinical Studies
Organization
Cochlear
clinicalstudies@cochlear.com
(303) 790-9010

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2015

First Posted

December 31, 2015

Study Start

January 1, 2016

Primary Completion

May 17, 2017

Study Completion

May 17, 2017

Last Updated

November 24, 2020

Results First Posted

November 10, 2020

Record last verified: 2020-11

Locations

US(4)