Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients

Hearing Loss, Sensorineural Clinical Trial

— DUAL  

Official title:

A Prospective, Single Centre, Single-blinded, Within-subject Investigation, on the Effect of Stimulation Parameter Changes, and Monopolar and Dual-electrode Mode Changes, on Speech Perception in Experienced Adult Cochlear Implant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298396
• Other study ID #: CLTD5853
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2024
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Cochlear
• Contact: Niva Shrestha
• Phone: +61296116177
• Email: nshrestha[@]cochlear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422)

• At least three months after activation of the cochlear implant.

• Eighteen years or older at the time of consent.

• User of 900Hz ACE (Advanced Combination Encoder) strategy MAP.

• Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear.

• Fluent speaker in English.

• Willing and able to provide written informed consent.

Exclusion Criteria:

• One or more electrodes turned off in the MAP used regularly.

• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.

• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.

• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.

• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• Program using default MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
• Program using low-power 1 (LP1) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
• Program using low-power 2 (LP2) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
• Program using low-power 3 (LP3) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.

Locations

Country	Name	City	State
Australia	Cochlear Macquarie	Macquarie Park	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Cochlear	Avania

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting	Speech perception in quiet will be measured using recorded CNC monosyllabic words at 60 dB SPL from S0 position to emulate conversational levels. The goal of speech perception assessment in quiet is to compare % words correct for each of the conditions.	week 4 and week 8
Primary	Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise	Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the SNR for 50% speech intelligibility.	week 4 and week 8
Secondary	Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting	Speech perception in quiet will be measured using recorded CNC monosyllabic words at 60 dB SPL from S0 position to emulate conversational levels. The goal of speech perception assessment in quiet is to compare % words correct for each of the conditions.	week 4 and week 8
Secondary	Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise	Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the SNR for 50% speech intelligibility.	week 4 and week 8
Secondary	Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting	Speech perception in quiet will be measured using recorded CNC monosyllabic words at 60 dB SPL from S0 position to emulate conversational levels. The goal of speech perception assessment in quiet is to compare % words correct for each of the conditions.	week 4 and week 8