NCT06298396: DUAL

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

Completed NA Results posted Last updated 17 December 2025

What this trial tests

NA trial testing Program using default MAP in Hearing Loss, Sensorineural in 20 participants. Completed in 16 December 2024.

Timeline

27 May 2024

Primary endpoint
16 December 2024

16 December 2024

Quick facts

Lead sponsor	Cochlear
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	27 May 2024
Primary completion	16 December 2024
Estimated completion	16 December 2024
Sites	1 location across Australia

Drugs / interventions tested

• Program using default MAP
• Program using low-power 1 (LP1) MAP
• Program using low-power 2 (LP2) MAP
• Program using low-power 3 (LP3) MAP

Conditions studied

• Hearing Loss, Sensorineural — all drugs for Hearing Loss, Sensorineural →

Sponsor

Cochlear — full company profile →

Who can join

18 and older, any sex, with Hearing Loss, Sensorineural. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet Primary · 10 participants completed this test at Week 4, and 10 participants completed this at week 8

Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.

Group	Value	95% CI
Sound processor MAP	-0.05	-2.92 – 2.81

Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise Primary · 10 participants completed the test at Week 4, 10 participants completed the test at Week 8

Speech perception in noise was 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 Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints.

Group	Value	95% CI
Sound processor MAP	-0.32	-0.87 – 0.24

Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet Secondary · 10 participants completed the test at Week 4, 10 participants completed the test at Week 8

Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each MAP. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.

Group	Value	95% CI
Sound processor MAP	0.45	-2.72 – 3.62

Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise Secondary · 10 participants completed this test at Week 4, and 10 participants completed this at week 8

Speech perception in noise was 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 Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints.

Group	Value	95% CI
Sound processor MAP	-0.23	-0.55 – 0.75

Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet Secondary · 10 participants completed this test at Week 4, and 10 participants completed this at week 8

Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.

Group	Value	95% CI
Sound processor MAP	-1.6	-5.15 – 1.95

Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise Secondary · 10 participants completed this test with at Week 4 and 10 participants completed this at week 8

Speech perception in noise was 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 Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints.

Group	Value	95% CI
Sound processor	-0.39	-1.10 – 0.32

Switching Acceptability Rating Between LP2 and LP3 MAPs Secondary · 10 participants were evaluated at week 4 and 10 participants were evaluated at week 8

Participants rated the sound quality when switching between the LP2 and LP3 MAPs with the investigator asking the question: How does the sound quality of the new program compare with the previous program in terms of sound quality? The possible responses being "very different, somewhat different, similar, or the same". The number of participants in each category will be reported.

Group	Value	95% CI
Sound processor	5
Sound processor	8
Sound processor	7
Sound processor	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Each participant was assessed from enrollment to final study visit, approximately 8 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Participants

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	All Participants
Viral infection	Infections and infestations	—

Data from ClinicalTrials.gov NCT06298396 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.