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NCT Number: NCT06680934

CABP2 Patient Registry and Natural History Study

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.

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Key information

Conditions

CABP2-related Auditory Synaptopathy Ear Diseases Hearing Disorders Hearing Impairment Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Goettingen

Göttingen, 37075, Germany

Location status: Recruiting

Location contact

Barbara Vona, PhD

CONTACT

[email protected]

+49-551-38-51337

Barbara Vona, PhD

SUB_INVESTIGATOR

Bernd Wollnik, MD

SUB_INVESTIGATOR

Nicola Strenzke, MD

SUB_INVESTIGATOR

Tobias Moser, MD

CONTACT

[email protected]

+49-551-39-63070

Tobias Moser, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with evidence of non-CABP2 molecular genetic diagnoses

Treatment and study plan

Molecular genetic testing and audiometry

Diagnostic Test

Genetic testing and audiometry are the interventions of interest

Primary outcomes

  1. Pure-tone audiometry

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

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

  2. Speech audiometry

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

    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

Secondary outcomes

  1. Otoacoustic emission thresholds

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

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

  2. Auditory brainstem response

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Vona, PhD

CONTACT

[email protected]

+49-551-38-51337

Tobias Moser, MD

CONTACT

[email protected]

+49-551-39-63070

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Official study title

Patient Registry for Individuals With CABP2-Associated Hearing Loss

Important dates

Study start
2024
Primary completion
2049
Study completion
2049
First posted
Nov 8, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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