- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03149484
Use of RM Technology in Pediatric BAI Recipients
April 25, 2023 updated by: Hillary A Snapp, University of Miami
Remote Microphone Technology in Pediatric Bone Anchored Implant Recipients
The purpose of this research study is to learn about the hearing outcomes of children with conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this research study is to learn about the hearing outcomes of children with unilateral conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology.
It has been shown that the use of intervention (hearing aids, cochlear implants, bone conduction devices) alone does not alleviate the difficulties children with hearing loss encounter in noisy environments such as a classroom or restaurant.
One of the most common methods to help children hear better in these types of environments is the use of a personal remote microphone (RM) system.
This study will evaluate how much benefit children are getting from their bone conduction device alone compared to the bone conduction device with a personal RM system.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami Department of Otolaryngology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
English speaking pediatric conduction device users ages 5 to 18 and their parent/guardian will be included for study.
These pediatric patients have a unilateral conductive hearing loss with a minimum of a 30 dB air-bone gap.
Description
Inclusion Criteria:
- English speaking
- unilateral conductive hearing loss with a minimum of a 30 dB air-bone gap and their parent/guardian
Exclusion Criteria:
- Do not meet inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric Group
Children with unilateral conductive hearing loss who are treated with bone conductive devices
|
Speech perception in noise performance will be evaluated in the unaided, bone conduction device (BAHA) aided, and bone conduction device (BAHA) + RM conditions.
All test measures are non-experimental and commercially available.
These subjective questionnaires will be given pre- and post-evaluation to both the subject and their guardian in order to determine the impact of RM on subject and guardian perceptions of listening in noise.
|
Parent/Guardian Group
The parent or guardian of a child with unilateral conductive hearing loss who are treated with bone conductive devices
|
These subjective questionnaires will be given pre- and post-evaluation to both the subject and their guardian in order to determine the impact of RM on subject and guardian perceptions of listening in noise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech Understanding in Noise
Time Frame: 40 minutes
|
Investigate benefit of remote microphone (RM) for listening in noise in children with bone conduction hearing devices by calculating SNR loss
|
40 minutes
|
Parent and Child Perception of Hearing Loss Questionnaire
Time Frame: 20 minutes
|
Determine the parent and child perception of the hearing loss and its impact pre- and post-evaluation using a subjective questionnaire created to further understand the child and parent's perception of their disability.
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hillary Snapp, AuD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2017
Primary Completion (Actual)
April 11, 2019
Study Completion (Actual)
April 11, 2019
Study Registration Dates
First Submitted
May 4, 2017
First Submitted That Met QC Criteria
May 9, 2017
First Posted (Actual)
May 11, 2017
Study Record Updates
Last Update Posted (Actual)
April 27, 2023
Last Update Submitted That Met QC Criteria
April 25, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20170224
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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