CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers (NCT04794179) | Clinical Trial Compass
CompletedNot Applicable
CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers
United States16 participantsStarted 2019-11-06
Plain-language summary
The purpose of this study is to assess the effect of the Naida Link contralateral routing of signal (CROS) device on speech understanding in challenging listening situations and on the quality of life in unilateral CI recipients and their frequent communication partners. We hypothesize that:
1. Unilateral CI recipients will obtain higher speech understanding scores with the CROS device in challenging listening conditions
2. Use of the CROS device will lead to positive changes in ratings on Quality of Life measures for (i) unilateral CI recipients, and (ii) their frequent communication partners
A frequent communication partner (FCP) is an individual (a family member, or a friend, or a care taker, or a significant other, or a colleague, etc.) who has at least two hours of in-person interactions with the CI recipient every week.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Unilateral recipients of Advanced Bionics CII/90K/Ultra implants
* Ages 18 years and above
* At least 6 months of CI use experience
* Current users of a Naida CI Q70 or Q90 processor
* Do not currently use a Naida Link CROS device
* Limited usable/aidable hearing in the contralateral ear
* Fluent in spoken English
* Willingness to use the CROS device regularly for the study duration
* Willingness to follow-up on a biweekly/monthly basis
Exclusion Criteria:
* \< 6 months of CI use experience
* \< 30% sentence recognition scores in quiet with unilateral CI
* Inability to participate in speech testing
* Inability to follow and complete questionnaires
* Inability to designate an FC
* not a unilateral recipient of Advanced Bionics CII/90K/Ultra implants
Frequent communication partner (FCP) participants' inclusion criteria:
* Ages 18 years and above
* Fluent in spoken English
* Willingness to participate in the study
* Spends at least two hours of in-person interactions with the recipient of Advanced Bionics CII/90K/Ultra implants every week.
FCP's Exclusion criteria:
* Under the age of 18 years
* Not fluent in spoken English
* Spends less than two hours of in-person interactions with the recipient of Advanced Bionics CII/90K/Ultra implants per week
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Speech Recognition
Timeframe: At baseline (enrollment visit), with a duration of 50 minutes