Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT05174104
Eligibility Criteria:
Inclusion Criteria:
* unilateral vestibular hypofunction achieved according to accepted criteria, by bithermal caloric irrigation, showing at least 25% reduced vestibular response on one side when calculated by means of Jongkees' formula, 3 months or later after symptom onset. In order to avoid confounding factors, and following previous experiences, only subjects presenting with a concurrent reduction in vestibulo-ocular reflex (VOR) gain when studied by means of video head impulse test will be included in this study.
Exclusion Criteria:
* History of falls, cardiovascular, metabolic, rheumatologic, orthopedic, or other neurological conditions, liver or renal abnormalities.
* pregnancy or breastfeeding.
* Neurological and neuro-psychiatric diseases
* insulin-dependent diabetes, vitamin deficiencies, hypothyroidism, lung diseases, hepatitis, chronic kidney failure, and Cushing syndrome
* medication possibly impacting on cochleo-vestibular function or with a history of drug or alcohol addiction
* inability to understand and agree to the examination procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05174104
Study Brief:
Protocol Section:
NCT05174104