CABP2 Patient Registry and Natural History Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Medical Center Goettingen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A molecular genetic diagnosis involving biallelic variants in CAPB2 and audiometry
Disqualifiers
Patients with evidence of non-CABP2 molecular genetic diagnoses
Trial population
Individuals with hearing impairment who have a molecular genetic diagnosis involving CABP2
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Molecular genetic testing and audiometry
Diagnostic testGenetic testing and audiometry are the interventions of interest
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: CABP2 participant group1 intervention
Trial outcomes
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 consent2
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 consentSecondary 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 consent2
Auditory brainstem response
Auditory brainstem response tests the functional status of the auditory neural pathway
Time frame
1 year, year 1, according to participant consentSponsors and contacts
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Source ClinicalTrials.gov