Evaluation of Alpha-Tectorin, Interleukin-10, and Thiol-Disulfide Homeostasis in Individuals With Congenital Hearing Loss
Sponsor study identifier
observational
120
1 country
1
Study Start
April 20, 2026
Actual (reported)Primary Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2026
Actual (reported)October 1, 2026
Actual (reported)October 6, 2026
Actual (reported)February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Serum alpha-tectorin level
Serum alpha-tectorin concentration measured by ELISA, compared among the cochlear implant, hearing aid and healthy control groups.
At enrollment (single blood sample)
Serum interleukin-10 (IL-10) level
Serum IL-10 concentration measured by ELISA, compared among the cochlear implant, hearing aid and healthy control groups.
At enrollment (single blood sample)
Serum thiol-disulfide homeostasis parameters
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.
Children under 18 years of age with audiologically confirmed congenital sensorineural hearing loss who have undergone cochlear implantation and actively use the implant (n=40).
Children under 18 years of age with audiologically confirmed congenital sensorineural hearing loss who have not undergone cochlear implantation and actively use hearing aids (n=40).
Age- and sex-matched healthy children under 18 years of age with normal audiological evaluation and no history of hearing loss (n=40).
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.
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Children under 18 years of age with congenital sensorineural hearing loss who use cochlear implants or hearing aids, and age- and sex-matched healthy children with normal hearing, evaluated at the Otorhinolaryngology and Audiology clinics of Harran University Faculty of Medicine Hospital, Sanliurfa, Turkey.
Harran University Faculty of Medicine Hospital, Department of Otorhinolaryngology
Sanliurfa, 63300, Turkey (Türkiye)
Serum samples obtained from approximately 5 mL of venous blood, stored at -80 C until analysis of alpha-tectorin, interleukin-10 and thiol-disulfide homeostasis parameters.
Servet Erdemes, MD
Harran University
First Submitted
October 1, 2026
First Posted
October 6, 2026
Study Start
April 20, 2026
Actual (reported)Primary Completion
February 2027
EstimatedAt enrollment (single blood sample)
Correlation of biomarker levels with degree of hearing loss
At enrollment (single blood sample)
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 6, 2026
Record last verified: 2026-10
Individual participant data will not be shared in order to protect participant confidentiality in accordance with national personal data protection regulations (KVKK).
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Source: ClinicalTrials.gov.
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