NCT05633693 Postural Sway and Counterpressure Maneuvers for Pediatric Syncope
| NCT ID | NCT05633693 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Simon Fraser University |
| Condition | Syncope, Vasovagal |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-04-17 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-04-17 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators are interested in whether discrete counterpressure maneuvers, or muscle movements in the lower body, will boost blood pressure and cardiovascular control in children who faint. We will record cardiovascular responses to maneuvers of exaggerated sway, leg crossing, crouching, and gluteal muscle tensing in children who faint (N=20), as well as their height, weight, muscularity, and pubertal (Tanner) stage. Autonomic cardiovascular control will be measured using a Valsalva manoeuvre (expiration against a closed airway for 20 seconds) and a supine-stand test. The primary outcomes are noninvasive measures of cardiovascular responses to the maneuvers (blood pressure, cerebral blood flow, and stroke volume (volume of blood pumped per heartbeat). Comparisons will be made across levels of sex, diagnosis, Tanner stage, muscularity, height, and degree of autonomic control.
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.
Contact & Investigator
Victoria E Claydon, PhD
PRINCIPAL INVESTIGATOR
Simon Fraser University
Frequently Asked Questions
Who can join the NCT05633693 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Syncope, Vasovagal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05633693 currently recruiting?
Yes, NCT05633693 is actively recruiting participants. Contact the research team at erin_williams_2@sfu.ca for enrollment information.
Where is the NCT05633693 trial being conducted?
This trial is being conducted at Burnaby, Canada.
Who is sponsoring the NCT05633693 clinical trial?
NCT05633693 is sponsored by Simon Fraser University. The principal investigator is Victoria E Claydon, PhD at Simon Fraser University. The trial plans to enroll 30 participants.