NCT04987021: RAL

An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients

Completed NA Results posted Last updated 21 February 2024

What this trial tests

NA trial testing Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants in Hearing Loss, Sensorineural in 15 participants. Completed in 28 January 2022.

Timeline

27 August 2021

Primary endpoint
28 January 2022

28 January 2022

Quick facts

Lead sponsor	Cochlear
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	15
Start date	27 August 2021
Primary completion	28 January 2022
Estimated completion	28 January 2022
Sites	1 location across Australia

Drugs / interventions tested

• Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants

Conditions studied

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

Sponsor

Cochlear — full company profile →

Who can join

18 and older, any sex, with Hearing Loss, Sensorineural or Hearing Loss, Bilateral. 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.

Number of Participants Who While Using the Final Version of Remote Assist, Are Able to Complete the Primary Tasks (Score of 5 on the Usability Rating Scale) Primary · Immediately after the participants´ first use of the Nucleus Smart App with Remote Assist Custom Sound Pro 6.3, on average half an hour after participants have completed all tasks.

Usability rating scale: 1 = unable to complete; 2 = Completed after help using document; 3 = Completed after trying an incorrect option; 4 = Completed after some exploration; 5 = Complete at first attempt.

Group	Value	95% CI
Nucleus Smart App With Remote Assist Custom Sound Pro 6.3	13

Adverse events — posted to ClinicalTrials.gov

Time frame: One day. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nucleus Smart App With Remote Assist Custom Sound Pro 6.3

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (1 terms — click to expand)

Reaction	System	Nucleus Smart App With Rem…
Sound levels uncomfortably loud	Investigations	—

Data from ClinicalTrials.gov NCT04987021 adverse events section.

Sponsor's own description

Clinical management of cochlear implant (CI) recipients involve programming, counselling, performance evaluation and habilitation. This requires the recipients to travel to the clinic for follow up appointments which can pose significant challenges for recipients, particularly those who live far away from the clinic. Remote Assist (RA) is a new solution that allows the clinician to make MAP and sound processor adjustments via the recipient's Nucleus Smart app (NSA) installed on their smart phone. With RA the clinician can also perform counselling using a video call directly via the NSA. As RA uses no specialized hardware and software that needs to be sent and retrieved back from the recipient, it has the potential to further improve the remote programming experience and convenience for both the recipient and the clinician.

Publications & conference data

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