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Clinical Trials in Turkey / NCT07860580
Recruiting Observational

Alpha-Tectorin, Interleukin-10 and Thiol-Disulfide Homeostasis in Children With Congenital Hearing Loss

NCT07860580 · tracked via the Priya Life Science Turkey tracker
Sponsor
Harran University
Phase
Observational
Started
2026-04-20
Last updated
2026-10-06

Condition(s) studied

Congenital Hearing LossSensorineural Hearing Loss

Investigational drug(s) / intervention(s)

Blood sample collection

Blood sample collection: Collection of approximately 5 mL of venous blood for measurement of serum alpha-tectorin, interleukin-10 and thiol-disulfide homeostasis parameters; no additional intervention is applied.

Study summary

Congenital hearing loss is one of the most common sensory disorders of childhood, and the structural, immunologic and oxidative mechanisms involved in its development are incompletely understood. This case-control study aims to evaluate serum alpha-tectorin and interleukin-10 (IL-10) levels and thiol-disulfide homeostasis in children with congenital sensorineural hearing loss (cochlear implant users and hearing aid users) compared with healthy children with normal hearing. The findings are expected to contribute to a better understanding of the mechanisms underlying congenital hearing loss and to the identification of potential diagnostic and prognostic biomarkers.

Eligibility

Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Serum alpha-tectorin level — At enrollment (single blood sample)
    Serum alpha-tectorin concentration measured by ELISA, compared among the cochlear implant, hearing aid and healthy control groups.
  • Serum interleukin-10 (IL-10) level — At enrollment (single blood sample)
    Serum IL-10 concentration measured by ELISA, compared among the cochlear implant, hearing aid and healthy control groups.
  • Serum thiol-disulfide homeostasis parameters — At enrollment (single blood sample)
    Native thiol, total thiol and disulfide levels (umol/L) and disulfide/native thiol, disulfide/total thiol and native thiol/total thiol ratios measured by an automated spectrophotometric method, compared among the cochlear implant, hearing aid and healthy control groups.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07860580 on ClinicalTrials.gov ↗ ← All trials in Turkey