Alpha-Tectorin, Interleukin-10 and Thiol-Disulfide Homeostasis in Children With Congenital Hearing Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorHarran University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Blood sample collection
Other interventionCollection 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.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Cochlear Implant Group1 intervention
Group B: Hearing Aid Group1 intervention
Group C: Healthy Control Group1 intervention
Trial outcomes
Primary outcomes
1
Serum alpha-tectorin level
Serum alpha-tectorin concentration measured by ELISA, compared among the cochlear implant, hearing aid and healthy control groups.
Time frame
At enrollment (single blood sample)2
Serum interleukin-10 (IL-10) level
Serum IL-10 concentration measured by ELISA, compared among the cochlear implant, hearing aid and healthy control groups.
Time frame
At enrollment (single blood sample)3
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.
Time frame
At enrollment (single blood sample)Secondary outcomes
1
Correlation of biomarker levels with degree of hearing loss
Correlation of serum alpha-tectorin, IL-10 and thiol-disulfide parameters with the degree of hearing loss (mild, moderate, severe, profound) determined by audiological evaluation, and with device type and duration of device use, in children with congenital hearing loss.
Time frame
At enrollment (single blood sample)Sponsors and contacts
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Source ClinicalTrials.gov