Biomarkers in Congenital Hearing Loss: Alpha-Tectorin, IL-10, and Thiol-Disulfide Balance in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cross-sectional, case-control study compares serum alpha-tectorin, interleukin-10, and thiol-disulfide homeostasis among three groups: children with congenital sensorineural hearing loss using cochlear implants, children with congenital hearing loss using hearing aids, and healthy age- and sex-matched controls. Blood samples are collected to measure biomarkers by ELISA and assess redox balance, aiming to illuminate potential diagnostic or prognostic markers. The study is conducted at Harran University and includes detailed clinical data collection, ensuring informed consent and ethical oversight. Results may contribute to understanding mechanisms of congenital hearing loss and its relation to oxidative stress and immunologic factors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Congenital Hearing Loss Groups (Cochlear Implant Group and Hearing Aid Group)

* Age under 18 years
* Congenital sensorineural hearing loss diagnosed at the Otorhinolaryngology outpatient clinic and confirmed by audiological testing (auditory brainstem response, otoacoustic emissions and/or pure-tone audiometry)
* Active use of a cochlear implant (Cochlear Implant Group) or active use of a hearing aid without cochlear implantation (Hearing Aid Group)
* No condition preventing collection of a peripheral blood sample
* Written informed consent from the parent or legal guardian

Healthy Control Group

* Age under 18 years
* No diagnosis of hearing loss and normal audiological evaluation
* No condition preventing collection of a peripheral blood sample
* Written informed consent from the parent or legal guardian

Exclusion Criteria (all groups):

* Syndromic hearing loss
* Acute infection, chronic inflammatory disease, autoimmune disease or other systemic disease
* History of malignancy or active malignant disease
* Immunodeficiency or use of immunosuppressive therapy
* Use of systemic corticosteroids, biologic agents or immunomodulatory therapy within the last 4 weeks

Where it's running

• Harran University Faculty of Medicine Hospital, Department of Otorhinolaryngology
  Sanliurfa, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Servet Erdemes, MD — Harran University
• Study coordinator: Kemal Özgen, MD
• Email: kemal.ozgen47@harran.edu.tr
• Phone: +905422272347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.