What side effects are associated with this type of intervention?

Common treatments for congenital hearing loss include hearing aids, cochlear implants, and surgical interventions. Hearing aids generally have minimal side effects but may cause discomfort or skin irritation. Cochlear implants can lead to surgical risks such as infection, device malfunction, and, in rare cases, facial nerve damage. Both treatments require ongoing adjustments and monitoring to ensure effectiveness and comfort. The Patient Navigator trial aims to facilitate timely care, improve compliance with these treatments, and enhance parental knowledge, which can help mitigate some of these side effects by ensuring proper use and follow-up.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of congenital hearing loss that directly align with the patient navigator trial's focus on timely care, compliance, and parental knowledge. However, cochlear implants are a significant FDA-approved intervention for congenital hearing loss. These devices have been approved for use in children as young as 12 months old and are designed to provide auditory stimulation to individuals with severe to profound hearing loss. The patient navigator model, while not a drug, complements these treatments by ensuring timely diagnosis, improving compliance with follow-up care, and enhancing parental understanding of the condition and its management.

What other types of research exist?

Promising alternatives to Patient Navigator for congenital hearing loss patients include: 1) Telehealth services, which provide remote consultations and follow-ups, ensuring timely care and convenience. 2) Mobile health applications that offer appointment reminders, educational resources, and progress tracking to improve compliance and parental knowledge. 3) AI-driven virtual assistants that can answer parents' questions, provide guidance, and offer emotional support. 4) Community health workers trained specifically in pediatric audiology to offer in-person support and education. 5) Online support groups and forums that connect parents with similar experiences, fostering a community of shared knowledge and support.

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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.)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months. (this is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.) for reporting.

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.

Do I qualify?Apply below to find out

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].