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Navigator Guidance for Hearing Loss (CHHIRP Trial)
N/A
Waitlist Available
Led By Matthew L Bush, MD, PhD
Research Sponsored by Matthew Bush, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months. (this is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests whether using a guide can help families of children with hearing loss get medical tests and keep appointments. The guide educates families about hearing loss, offers emotional support, and ensures they receive necessary care. The goal is to improve the scheduling of tests and increase appointment attendance.
Who is the study for?
This trial is for infants who failed a hearing screening in one or both ears before leaving the hospital after birth, and are referred for follow-up tests at specific clinics. It's also for parents who speak English or can use phone interpreting services. Families must live in Kentucky and not plan to move within three months.
What is being tested?
The study is testing whether having a patient navigator - someone to support, educate, and guide families - helps children with congenital hearing loss get their necessary hearing tests faster, improves appointment attendance, and increases parental knowledge about the condition.
What are the potential side effects?
Since this intervention involves guidance and support rather than medical treatment, there are no direct physical side effects. However, participants may experience varying levels of emotional or social impact due to the involvement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months. (this is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months. (this is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants who do not receive diagnostic audiological testing (Aim 1)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Navigator ArmActive Control1 Intervention
Examination of adherence to follow-up with a navigator.
Group II: Non-Intervention ArmActive Control1 Intervention
Examination of adherence to follow-up without a navigator.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for congenital hearing loss include hearing aids, cochlear implants, and early intervention programs. Hearing aids amplify sound, making it easier for the auditory system to process.
Cochlear implants bypass damaged parts of the ear and directly stimulate the auditory nerve, allowing for the perception of sound. Early intervention programs, often facilitated by patient navigators, provide timely audiological assessments, support compliance with treatment plans, and educate parents about hearing loss.
These interventions are crucial as they enhance auditory development, improve communication skills, and support overall cognitive and social development in children with congenital hearing loss.
Management of paediatric otogenic cerebral venous sinus thrombosis: a systematic review.[The role of neurobioregulation in the combined treatment of subjective tympanophonia and dizziness].
Management of paediatric otogenic cerebral venous sinus thrombosis: a systematic review.[The role of neurobioregulation in the combined treatment of subjective tympanophonia and dizziness].
Find a Location
Who is running the clinical trial?
Matthew Bush, MDLead Sponsor
3 Previous Clinical Trials
619 Total Patients Enrolled
2 Trials studying Deafness
606 Patients Enrolled for Deafness
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
354 Previous Clinical Trials
181,519 Total Patients Enrolled
40 Trials studying Deafness
38,282 Patients Enrolled for Deafness
National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,166,340 Total Patients Enrolled
9 Trials studying Deafness
16,124 Patients Enrolled for Deafness
Matthew L Bush, MD, PhDPrincipal InvestigatorAssociate Professor, Vice Chair of Research
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The baby did not pass a hearing test before leaving the hospital after birth.I can communicate in English or use Cyracom phone interpreting.
Research Study Groups:
This trial has the following groups:- Group 1: Navigator Arm
- Group 2: Non-Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.