Durham, NCNCT05775367Now EnrollingIRB Ready

Single Sided Deafness Clinical Trial in Durham, NC

Access cutting-edge single sided deafness treatment through this clinical trial at a research site in Durham. Study-provided care at no cost to qualified participants.

Sponsored by University of North Carolina, Chapel Hill

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Expert Care in Durham

Access single sided deafness specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related single sided deafness treatment provided free

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Check if you qualify for this single sided deafness clinical trial in Durham, NC

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Why Participate?

  • No-Cost Study Care

  • Local to Durham

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Durham site if eligible
  4. 4Begin participation

About This Single Sided Deafness Study in Durham

The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness. The main questions it aims to answer are: * Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers? * Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers? Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development. Children will be asked to: * Undergo cochlear implantation * Wear their cochlear implant processor whenever they are awake. * Participate in traditional hearing tests * Participate in traditional hearing testing * Participate in localization testing * Participate in hearing in noise testing * Participate in word recognition testing * Participate in speech, language, and educational evaluations The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.

Sponsor: University of North Carolina, Chapel Hill

Who Can Participate

Inclusion Criteria

To be eligible to participate in this trial as a study subject, an individual must meet all of the following criteria:
Provision of signed and dated parental permission form
Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as:
Unaided residual hearing thresholds that yield a 3 frequency pure tone average (PTA; average at 500, 1000, and 2000 Hz) of ≥70 dB hearing loss (HL) in the ear to be implanted
Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz). i. Thresholds should be measured using inserts wherever possible, or in the sound field to record the better-hearing ear alone. Required thresholds will include 250, 500, 1000, 2000, and 4000 Hz for air conduction. All other octave frequencies should be attempted. Bone conduction thresholds should be obtained at 500, 1000, 2000, and 4000 Hz. Masking should be attempted where appropriate. As participants are very young and masking is difficult for this population, suspected shadow audiograms will be sufficient if objective testing has confirmed a severe-to-profound unilateral hearing loss. Testing should confirm a severe-to-profound hearing loss, defined as a 3-frequency PTA (500, 1000, and 2000) \>70 dB HL in one ear and ≤20 dB HL in the contralateral ear. The Primary Investigator and Lead Diagnostic Audiologist must agree on this diagnosis for enrollment.
Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as:
PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or
Recorded Multisyllabic Lexical Neighborhood Test (MLNT) scores ≤ 30% in the ear to be implanted for children with the requisite language to complete open-set word recognition testing.
Between 7 months and 2 years, 11 months of age at implantation
Normal cochlear nerve as evaluated by imaging, required imaging by MRI brain/Internal auditory canal (IAC) without contrast with heavily weighted T2 images. CT optional at the physician's discretion.
No malformation of the cochlea
No evidence of progressive hearing loss of the contralateral ear
Willing to/has undergone hearing aid trial as warranted based on achieving an aided speech intelligibility index (SII) of \> .65 when fitted via Desired Sensation Level (DSL) methods.
Realistic parental expectations: a verbal acknowledgment of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing
Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations
Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2).
Parental commitment to study parameters including being able and willing to participate in the evaluation schedule, involvement in prescribed therapy, and travel to the investigational site and study-related activities. Parents must be willing to encourage wearing implant during waking hours. To participate as an SSD control subject, an individual must meet all the following criteria:
Provision of signed and dated parental permission form
Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age.
Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear.
Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz)
Unable to use or benefit from traditional amplification
Five years of age at the time of testing
Development and cognition within the normal range as measured by the Early Stanford Binet 2 (SB2). To participate as a TH control subject, an individual must meet all the following criteria:
Provision of signed and dated parental permission form
Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).
Five years of age at the time of testing
Development and cognition within the normal range as measured by the Early SB2. An individual who meets any of the following criteria will be excluded from participation in this study as a study subject:
English is not primary language of the home
Speech perception materials are presented in English
Parental questionnaires are administered in English
Conductive hearing loss in either ear
Cochlear nerve deficiency
Ossification/Fibrosis of the cochlea precluding implantation
Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
History of refractory chronic otitis media or condition that contraindicates anesthesia An individual who meets any of the following criteria will be excluded from participation in this study as a control subject:
English is not primary language of the home
Speech perception materials are presented in English
Parental questionnaires are administered in English
Inability to participate in testing (i.e., unwillingness)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Durham?

Yes, this clinical trial (NCT05775367) has an active research site in Durham, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Single Sided Deafness Treatment Options in Durham, NC

If you're searching for single sided deafness treatment options in Durham, NC, this clinical trial (NCT05775367) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Durham research site is actively enrolling participants for this clinical trial. You'll receive care from experienced single sided deafness specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all single sided deafness clinical trials near you to find additional studies recruiting in your area.

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