NCT03756337

Brief Summary

This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

November 26, 2018

Last Update Submit

October 13, 2021

Conditions

Hearing Loss, SensorineuralCochlear Hearing Loss

Keywords

cochlear implantsound processorupgrade

Outcome Measures

Primary Outcomes (1)

  • speech recognition in quiet

    Hearing In Noise Test

    Day 1

Secondary Outcomes (2)

  • speech recognition in noise

    Day 1

  • pure tone threshold

    Day 1

Study Arms (2)

Neuro 2 Upgrade

EXPERIMENTAL

Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested.

Device: Neuro 1 & Neuro 2

Neuro 1 Downgrade

EXPERIMENTAL

Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested.

Device: Neuro 2 & Neuro 1

Interventions

Neuro 1 & Neuro 2DEVICE

participant common fitting map used for tests

Neuro 2 Upgrade
Neuro 2 & Neuro 1DEVICE

participant common fitting map used for tests

Neuro 1 Downgrade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • primary implantation
  • subject having participated to previous Neuro 1 sound processor study in Canada
  • fluent in English, including reading and writing.

You may not qualify if:

  • psychologically unsuitable
  • unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device
  • non compliant with all investigational requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Hearing and Speech centres

Halifax, Canada

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

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

Study Officials

  • David Peter Morris, MD

    Dalhousie University, Halifax,NS, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 28, 2018

Study Start

November 1, 2019

Primary Completion

January 10, 2020

Study Completion

January 10, 2020

Last Updated

October 20, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)