Congenital Hearing LossNCT07860580
Alpha-Tectorin, Interleukin-10 and Thiol-Disulfide Homeostasis in Children With Congenital Hearing Loss
An observational study of Congenital Hearing Loss and Sensorineural Hearing Loss, run by Harran University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Hearing Loss, Sensorineural Hearing Loss
- What is being tested?
- Blood sample collection
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study 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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Harran University Faculty of Medicine Hospital, Department of Otorhinolaryngology
Sanliurfa, 63300
Kemal Özgen, MD, +905422272347, kemal.ozgen47@harran.edu.tr
About this study
Official title: Evaluation of Alpha-Tectorin, Interleukin-10, and Thiol-Disulfide Homeostasis in Individuals With Congenital Hearing Loss
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.
Read the detailed description
This cross-sectional case-control study is conducted at the Departments of Otorhinolaryngology and Audiology, Harran University Faculty of Medicine, Sanliurfa, Turkey. Pediatric patients with congenital sensorineural hearing loss confirmed by audiological testing (auditory brainstem response, otoacoustic emissions and/or pure-tone audiometry) are enrolled prospectively in three groups: (1) children who have undergone cochlear implantation for congenital hearing loss and actively use the implant (n=40); (2) children with congenital hearing loss who have not undergone cochlear implantation and actively use hearing aids (n=40); and (3) age- and sex-matched healthy children with normal audiological evaluation (n=40).
Written informed consent is obtained from the legal guardians of all participants, and assent is obtained from the children where appropriate. Age, sex, birth history, perinatal risk factors, comorbidities, medications, degree of hearing loss, device type and duration of device use are recorded using a standard data collection form.
Approximately 5 mL of venous blood is collected from each participant. Serum is separated by centrifugation and stored at -80 C until analysis. Serum alpha-tectorin and IL-10 levels are measured quantitatively with commercial enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturers' instructions. Thiol-disulfide homeostasis (native thiol, total thiol and disulfide levels and their ratios) is determined with an automated spectrophotometric method.
Biochemical parameters are compared between groups and analyzed in relation to clinical characteristics and the degree of hearing loss. Normality is assessed with the Kolmogorov-Smirnov and/or Shapiro-Wilk tests. Group comparisons are performed with the independent samples t-test or Mann-Whitney U test, and one-way ANOVA or Kruskal-Wallis test, as appropriate; categorical variables are compared with the chi-square or Fisher's exact test. Correlations are evaluated with Pearson or Spearman analysis, and multivariable linear regression is used to identify factors associated with biomarker levels. A p value <0.05 is considered statistically significant.
- Being tested
- Blood sample collection
- Keywords
- Alpha-Tectorin, Interleukin-10, Thiol-Disulfide Homeostasis, Oxidative Stress, Cochlear Implant, Hearing Aid, Biomarker
- Medical subject headings
- Hearing Loss, Sensorineural, Deafness, Autosomal Dominant 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
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 group | Role | What they receive |
|---|---|---|
| Cochlear Implant Group | 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). Receives: Other: Blood sample collection | |
| Hearing Aid Group | 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). Receives: Other: Blood sample collection | |
| Healthy Control Group | Age- and sex-matched healthy children under 18 years of age with normal audiological evaluation and no history of hearing loss (n=40). Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum alpha-tectorin level
Serum alpha-tectorin concentration measured by ELISA, compared among the cochlear implant, hearing aid and healthy control groups.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At enrollment (single blood sample)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start20 Apr 2026
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Servet Erdemes, Harran University
- Investigators
- Servet Erdemes, MD, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860580
- Sponsor's protocol ID
- HRÜ26.05.39
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant confidentiality in accordance with national personal data protection regulations (KVKK).
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Alpha-Tectorin, Interleukin-10, and Thiol-Disulfide Homeostasis in Individuals With Congenital Hearing Loss
- ClinicalTrials.gov ID
- NCT07860580
- Acronym / sponsor ID
- HRÜ26.05.39
- Keywords
- Alpha-Tectorin, Interleukin-10, Thiol-Disulfide Homeostasis, Oxidative Stress, Cochlear Implant, Hearing Aid, Biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This cross-sectional case-control study is conducted at the Departments of Otorhinolaryngology and Audiology, Harran University Faculty of Medicine, Sanliurfa, Turkey. Pediatric patients with congenital sensorineural hearing loss confirmed by audiological testing (auditory brainstem response, otoacoustic emissions and/or pure-tone audiometry) are enrolled prospectively in three groups: (1) children who have undergone cochlear implantation for congenital hearing loss and actively use the implant (n=40); (2) children with congenital hearing loss who have not undergone cochlear implantation and actively use hearing aids (n=40); and (3) age- and sex-matched healthy children with normal audiological evaluation (n=40).
Written informed consent is obtained from the legal guardians of all participants, and assent is obtained from the children where appropriate. Age, sex, birth history, perinatal risk factors, comorbidities, medications, degree of hearing loss, device type and duration of device use are recorded using a standard data collection form.
Approximately 5 mL of venous blood is collected from each participant. Serum is separated by centrifugation and stored at -80 C until analysis. Serum alpha-tectorin and IL-10 levels are measured quantitatively with commercial enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturers' instructions. Thiol-disulfide homeostasis (native thiol, total thiol and disulfide levels and their ratios) is determined with an automated spectrophotometric method.
Biochemical parameters are compared between groups and analyzed in relation to clinical characteristics and the degree of hearing loss. Normality is assessed with the Kolmogorov-Smirnov and/or Shapiro-Wilk tests. Group comparisons are performed with the independent samples t-test or Mann-Whitney U test, and one-way ANOVA or Kruskal-Wallis test, as appropriate; categorical variables are compared with the chi-square or Fisher's exact test. Correlations are evaluated with Pearson or Spearman analysis, and multivariable linear regression is used to identify factors associated with biomarker levels. A p value <0.05 is considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant Group | – | Other: Blood sample collectionChildren under 18 years of age with audiologically confirmed congenital sensorineural hearing loss who have undergone cochlear implantation and actively use the implant (n=40). |
| Hearing Aid Group | – | Other: Blood sample collectionChildren 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). |
| Healthy Control Group | – | Other: Blood sample collectionAge- and sex-matched healthy children under 18 years of age with normal audiological evaluation and no history of hearing loss (n=40). |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionCollection 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. | Other | Cochlear Implant Group, Healthy Control Group, Hearing Aid Group |
Primary outcome
Serum alpha-tectorin level
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Correlation of biomarker levels with degree of hearing loss
Time frame: At enrollment (single blood sample)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect participant confidentiality in accordance with national personal data protection regulations (KVKK).
Related trials for Congenital Hearing Loss
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Pitch Perception and Memory: Deficits and Training
Cochlear Implants
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
RecruitingPhase 3
KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases
Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD)
RecruitingPhase 3
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Retinitis Pigmentosa (RP), Usher Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Servet Erdemes, MD principal investigator
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hearing Loss and Sensorineural Hearing Loss, run by Harran University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kemal Özgen, MD (+905422272347, kemal.ozgen47@harran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum alpha-tectorin level (time frame: At enrollment (single blood sample)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.