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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT05633693
Eligibility Criteria:
Inclusion Criteria:
We are looking for English speaking pediatric patients aged 6-18 years with a diagnosis of recurrent fainting (at least two episodes of fainting with loss of consciousness or near loss of consciousness in the last year) of a vasovagal origin or associated with the postural orthostatic tachycardia syndrome (POTS) (as determined by a paediatric cardiologist) to take part in this study.
Exclusion Criteria:
Those with a diagnosis of recurrent fainting accompanied by any of the following will not be eligible to take part:
Known history of:
* Suspected or confirmed cardiac arrhythmia (e.g., Wolff-Parkinson-White, Long QT)
* Traumatic head injury
* New presentation of a seizure disorder OR epilepsy recurrence
* Overdose or intoxication
* Structural heart disease
* Cardiovascular disease including hypertension, diabetes, or renal disease
* Hypoglycemia
* Physical and/or psychological disability that impact their ability to complete the tests
Female participants of childbearing age will be excluded if they are pregnant, or think they might be. Participants who are taking any cardiovascular acting medications, including treatment for cardiovascular disease, or medications for orthostatic syncope (e.g. fludrocortisone, slow-release sodium chloride, β-blockers, midodrine) will be excluded from the study.
In order to reduce the likelihood of transmission of COVID-19, participants will only be eligible to participate in the study if they have received full immunisation against COVID-19 according to current Health Canada guidelines. Accordingly, participants will be asked to provide evidence of their vaccination status in order to take part in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT05633693
Study Brief:
Protocol Section:
NCT05633693