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Use of RM Technology in Pediatric BAI Recipients

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ClinicalTrials.gov Identifier: NCT03149484
Recruitment Status : Enrolling by invitation
First Posted : May 11, 2017
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hillary A Snapp, University of Miami

Brief 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.

Condition or disease Intervention/treatment
Hearing Loss, Unilateral Device: Personal remote microphone (RM) system Other: Subjective Questionnaire

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remote Microphone Technology in Pediatric Bone Anchored Implant Recipients
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pediatric Group
Children with unilateral conductive hearing loss who are treated with bone conductive devices
Device: Personal remote microphone (RM) system
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.

Other: Subjective Questionnaire
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
Other: Subjective Questionnaire
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.




Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149484


Locations
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United States, Florida
University of Miami Department of Otolaryngology
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Hillary Snapp, AuD University of Miami

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Responsible Party: Hillary A Snapp, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03149484     History of Changes
Other Study ID Numbers: 20170224
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Unilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms