Hearing Loss, UnilateralNCT03149484
Use of RM Technology in Pediatric BAI Recipients
An observational study of Hearing Loss, Unilateral, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Hearing Loss, Unilateral
- What is being tested?
- Personal remote microphone (RM) system and Subjective Questionnaire
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2017to 11 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- English speaking
- unilateral conductive hearing loss with a minimum of a 30 dB air-bone gap and their parent/guardian
Who cannot join
- Do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Department of Otolaryngology
Miami, Florida, 33136
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss, Unilateral
- Being tested
- Personal remote microphone (RM) system, Subjective Questionnaire
- Medical subject headings
- Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal remote microphone (RM) systemDevice
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.
Subjective QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Group | Children with unilateral conductive hearing loss who are treated with bone conductive devices Receives: Device: Personal remote microphone (RM) system; Other: Subjective Questionnaire | |
| Parent/Guardian Group | The parent or guardian of a child with unilateral conductive hearing loss who are treated with bone conductive devices Receives: Other: Subjective Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Understanding in Noise
Investigate benefit of remote microphone (RM) for listening in noise in children with bone conduction hearing devices by calculating SNR loss
Measured: 40 minutes
Parent and Child Perception of Hearing Loss Questionnaire
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start2 May 2017
- Primary completion11 Apr 2019
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, UnilateralStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hillary A Snapp, University of Miami
- Investigators
- Hillary Snapp, AuD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149484
- Sponsor's protocol ID
- 20170224
- Status last verified
- Apr 2023
- First submitted
- 4 May 2017
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Microphone Technology in Pediatric Bone Anchored Implant Recipients
- ClinicalTrials.gov ID
- NCT03149484
- Acronym / sponsor ID
- 20170224
- Conditions
- Hearing Loss, Unilateral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Group | – | Device: Personal remote microphone (RM) system, Other: Subjective QuestionnaireChildren with unilateral conductive hearing loss who are treated with bone conductive devices |
| Parent/Guardian Group | – | Other: Subjective QuestionnaireThe parent or guardian of a child with unilateral conductive hearing loss who are treated with bone conductive devices |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- English speaking
- unilateral conductive hearing loss with a minimum of a 30 dB air-bone gap and their parent/guardian
Key exclusion criteria (1 listed)
- Do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal remote microphone (RM) systemSpeech 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. | Device | Pediatric Group |
| Subjective QuestionnaireThese 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. | Other | Parent/Guardian Group, Pediatric Group |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hillary Snapp, AuD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Unilateral, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Understanding in Noise (time frame: 40 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.