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Speech Language Therapy + Digital Storybook for Childhood Hearing Loss

N/A
Waitlist Available
Led By Prasanth Pattisapu, MD
Research Sponsored by Prashant Malhotra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bilateral Sensorineural or mixed hearing loss at least (PTA≥30dB)
Male and female children ages 3.0-5.11 (5 years and 11 months) at time of initial assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12- month intervention period
Awards & highlights

Study Summary

This trial will compare the effects of adding a digital storybook intervention to in-person speech-language therapy for young children who are deaf or hard of hearing.

Who is the study for?
This trial is for children aged 3 to nearly 6 with bilateral sensorineural or mixed hearing loss, including auditory neuropathy in both ears. It's not suitable for kids where English isn't the primary language or those who score more than 2 standard deviations from normal on a specific language test (CELF-P3).Check my eligibility
What is being tested?
The study compares traditional in-person speech-language therapy with and without the addition of a digital storybook platform called 'Hear Me Read' to see if it improves vocabulary, speech, language, and literacy in young children with hearing loss.See study design
What are the potential side effects?
Since this trial involves educational interventions like speech therapy and digital applications rather than medical treatments, there are no typical side effects as one would expect from medication. However, individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have hearing loss in both ears.
Select...
My child is between 3 and 5 years old.
Select...
I have hearing loss in both ears due to nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12- month intervention period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12- month intervention period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Expressive Language Index
Clinical Evaluation of Language Fundamentals Preschool- 3 and Indices: Receptive Language Index
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Basic Concepts
+8 more
Secondary outcome measures
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Phonological Awareness
Clinical Evaluation of Language Fundamentals Preschool- 3 and subtests: Preliteracy Rating Scale
Clinical Evaluation of Language Fundamentals Preschool-3 Index: Early Literacy Index

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Speech Language Therapy + Digital PhaseExperimental Treatment2 Interventions
Children who are deaf/hard of hearing will receive standard of care speech and language therapy with a speech language pathologist with the addition of the digital app named, Hear Me Read, that will be used to achieve reading, speech and language goals through interactive digital storybook reading. Reading time is prescribed 20 min, 3x/week.
Group II: Speech Language TherapyActive Control1 Intervention
Children who are deaf/hard of hearing will receive standard of care speech and language therapy with a speech language pathologist. Reading time is prescribed 20 min, 3x/week.

Find a Location

Who is running the clinical trial?

Prashant MalhotraLead Sponsor
Prasanth PattisapuLead Sponsor
Clinical and Translational Intramural Funding Program from the Abigail Wexner Research InstituteUNKNOWN

Media Library

Speech Language Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05245799 — N/A
Hearing Loss Research Study Groups: Speech Language Therapy, Speech Language Therapy + Digital Phase
Hearing Loss Clinical Trial 2023: Speech Language Therapy Highlights & Side Effects. Trial Name: NCT05245799 — N/A
Speech Language Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245799 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study extend to individuals in their seventies?

"This clinical trial specifically seeks out children aged 3 to 5. In addition, there are 306 studies targeting minors and 763 trials designed for elderly patients."

Answered by AI

Are researchers actively looking for participants in this research project?

"Clinicaltrials.gov clarifies that this particular medical trial, which had its first posting on March 25th 2022 and was last edited on September 20th 2022, is not presently enrolling participants. However, there are 1110 other trials currently recruiting patients worldwide."

Answered by AI

Do I meet the criteria for enrollment in this trial?

"Participants aged between 3 and 5 years old with the support of speech therapy are eligible to join this trial. A total of 50 patients will be selected in the experiment."

Answered by AI
~17 spots leftby Apr 2025