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RecruitingNCT06680934Updated Jan 27, 2026

CABP2 Patient Registry and Natural History Study

An observational study in CABP2-related Auditory Synaptopathy and Hearing Impairment, sponsored by University Medical Center Goettingen. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by University Medical Center Goettingen · Observational

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
100
Sex
All
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Study summary

This registry is designed to collect comprehensive information about the molecular genetic diagnoses and clinical information of individuals with CABP2-associated hearing impairment to support a natural history study.

Read the detailed description

A patient registry, in both German and English languages, has been established for patients with hereditary hearing impairment due to variants in CABP2. The study is conducted in accordance with the current version of the Declaration of Helsinki. The study protocol and database structure have been approved by the Ethics Committee of the University Medical Center Goettingen.

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Conditions studied

  • CABP2-related Auditory Synaptopathy
  • Hearing Impairment

Browse trials for

Keywords

  • CABP2 patient registry
  • Patient registry
  • DFNB93
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In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 100 is above the median of 87 across 270 observational studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

University Medical Center Goettingen is the lead sponsor of 61 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals with hearing impairment who have a molecular genetic diagnosis involving CABP2

Inclusion criteria

  • A molecular genetic diagnosis involving biallelic variants in CAPB2 and audiometry

Exclusion criteria

Exclusion Criteria:

  • Patients with evidence of non-CABP2 molecular genetic diagnoses
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Study design

Observational model
Case-only
Time perspective
Other
Enrollment
100 participants (estimated)
Target follow-up
25 Years
Patient registry
Yes

Groups and cohorts

  • CABP2 participant group

    Individuals with hearing impairment who have a molecular genetic diagnosis involving CABP2

    Diagnostic Test: Molecular genetic testing and audiometry

Interventions

  • Diagnostic testMolecular genetic testing and audiometry

    Genetic testing and audiometry are the interventions of interest

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What researchers measure

Primary outcomes

  1. Pure-tone audiometry

    Pure tone audiometry is a behavioral hearing test used to measure an individual's hearing threshold levels

    Time frame: 1 year, year 1, according to participant consent

  2. Speech audiometry

    Speech audiometry is a test or series of tests to determine a patient's ability to discriminate speech sounds and hearing speech or speech in noise

    Time frame: 1 year, year 1, according to participant consent

Secondary outcomes

  1. Otoacoustic emission thresholds

    Otoacoustic emission thresholds serve as indicators of integrity and function of the outer hair cells in the cochlea

    Time frame: 1 year, year 1, according to participant consent

  2. Auditory brainstem response

    Auditory brainstem response tests the functional status of the auditory neural pathway

    Time frame: 1 year, year 1, according to participant consent

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Study locations

1 of 1 sites recruiting
  • University Medical Center Goettingen
    Göttingen, 37075, Germany
    • Barbara Vona, PhD · Contact · barbara.vona@med.uni-goettingen.de · +49-551-38-51337
    • Tobias Moser, MD · Contact · tmoser@gwdg.de · +49-551-39-63070
    • Tobias Moser, MD · Principal investigator
    • Bernd Wollnik, MD · Sub investigator
    • Nicola Strenzke, MD · Sub investigator
    • Barbara Vona, PhD · Sub investigator
    Recruiting
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References and documents

Publications

  • Vona B, Wollnik B, Strenzke N, Pangrsic T, Moser T. Is CABP2-Associated Hearing Loss (DFNB93) a Gene Therapy Target? Preclinical Progress and Patient Registry. MedComm (2020). 2025 Sep 8;6(9):e70363. doi: 10.1002/mco2.70363. eCollection 2025 Sep. PubMed 40927552 ↗

Study documents

  • Study protocol · May 16, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Pseudonymized data will be published in publications

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06680934
Lead sponsor
University Medical Center Goettingen
Responsible party
Tobias Moser (Prof., University Medical Center Goettingen) — Principal investigator
First posted
Nov 8, 2024
Start date
Aug 16, 2024
Primary completion
Aug 16, 2049 (estimated)
Completion
Aug 16, 2049 (estimated)
Last update
Jan 27, 2026

Study contacts

Barbara Vona, PhD
Contact
barbara.vona@med.uni-goettingen.de
+49-551-38-51337
Tobias Moser, MD
Contact
tmoser@gwdg.de
+49-551-39-63070
Tobias Moser, MD
study director · University Medical Center Goettingen
Bernd Wollnik, MD
principal investigator · University Medical Center Goettingen
Nicola Strenzke, MD
principal investigator · University Medical Center Goettingen
Barbara Vona, PhD
principal investigator · University Medical Center Goettingen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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