An interventional study of Counterpressure Maneuvers and Baseline Stand in Syncope, Vasovagal, Postural Orthostatic Tachycardia Syndrome and Orthostatic Intolerance, sponsored by Simon Fraser University. Recruiting at 1 site in Canada. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Simon Fraser University · Not applicable, Interventional, and Treatment
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Among 15 studies in Syncope, Vasovagal with a site in Canada — 7 open to participants now, 9 under way, 1 of them phase 3. Syncope, Vasovagal · Canada.
Among the 15 studies in Syncope, Vasovagal with a site in Canada, this one is the 11th largest by planned enrollment of the 14 interventional ones that give a count, is one of 3 that started in 2023, is one of 8 with no phase, and was the 13th registered.
88 studies on the registry are indexed under Syncope, Vasovagal; 28 are open to participants now.
Browse Syncope, Vasovagal studies →7 of the 15 studies in Syncope, Vasovagal with a site in Canada are open now. Recruiting first, the newest first:
Simon Fraser University · Sites in Canada
Ages 18–50 · Healthy volunteers
Simon Fraser University · Sites in Canada
Ages 19–50 · Healthy volunteers
University of Calgary · Sites in Canada
Ages 18–100
Dr. Victoria Claydon · Sites in Canada
Ages 6–18
University of Calgary · Sites in Canada
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 24 Syncope, Vasovagal studies recruiting now, 13 (54%) set no upper age limit and 8 (33%) stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.
This study: 6 Years to 18 Years · all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 3 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 59 across 58 interventional studies indexed under Syncope, Vasovagal.
Median enrollment 74 across the 14 interventional studies, 200 across the 1 observational. Of the 5 that completed or were terminated, 3 (60%) have results posted.
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1 of 15 have an industry lead sponsor. The 8 most frequent:
Simon Fraser University is the lead sponsor of 29 studies on the registry; 6 are open to participants now.
Simon Fraser University has 3 studies filed under Syncope, Vasovagal — fewer than ten, so there is no comparison to draw.
5 of the studies in Syncope, Vasovagal with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06336031Simon Fraser UniversityImpact of Blood Phobia on Fainting Susceptibility | 2026-12 |
| NCT03446326University of CalgaryAssessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates | 2027-01-01 |
| NCT05621460Simon Fraser UniversityThe Effect of Water Carbonation on Orthostatic Tolerance | 2027-04 |
| NCT05633693Simon Fraser UniversityPostural Sway and Counterpressure Maneuvers for Pediatric Syncope | 2027-05 |
| NCT05555771Dr. Victoria ClaydonPaediatric Syncope in the Emergency Department | 2027-09-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 15 studies in Syncope, Vasovagal with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Purpose: The primary purpose of this investigation is to determine whether discrete counterpressure maneuvers (CPM; exaggerated sway, rhythmic gluteal muscle clenching) can demonstrably improve the return of blood to the heart and the blood pressure in paediatric patients with recurrent uncomplicated syncope (fainting), and to assess whether these discrete CPM are more effective than those commonly recommended in the clinic (leg crossing, crouching).
Protocol: Volunteers (n=35) will be asked to attend one testing session. Testing will take approximately 1.5 hours. Tests will usually be conducted in the mornings. On the day of the test volunteers will be asked to have only a light breakfast avoiding caffeine, and should avoid strenuous exercise for at least 12 hours prior to testing. Female participants that have reached menarche will be asked to make a note of the date of their last period (we would prefer to schedule testing on a day when they do not have, or expect, their period because this may influence orthostatic tolerance).
Prior to testing volunteers will be asked a brief narrative medical history including questions regarding their syncopal diagnosis, and as to whether they have any known cardiovascular or neurological disease, are taking any medications, and questions about general cardiovascular risk factors such as smoking, and alcohol consumption. Participants will also be asked to complete a short questionnaire about their fainting spells. All participants will be asked to self-identify their stage in pubertal development ("Tanner" stage) based on drawn images of biologically male and female bodies at each stage. If participants to not identify with these images, have difficulty answering the question, or do not wish to answer for any reason, they do not have to do so (and are not required to provide this reason). Participants will then complete the PEDS-QL (Pediatric Quality of Life Inventory) and PAQ (Physical Activity Questionnaire). Measures of height, weight and muscle mass will be taken using a height chart and impedance-based weighing scale. Anthropometric measurements of body composition (skinfold thickness: bicep, tricep, thigh, medial calf; circumference: mid-upper arm, mid-thigh, mid-calf) will also be performed. A copy of the prompt sheet used by the investigators to facilitate taking the medical history is included with the submission. This form outlines the medical history data collected in general terms and is used to guide a narrative history. Participants will be asked to empty their bladder in the nearby washroom, and to retain a sample of their urine for testing for sodium levels (a marker of salt intake and hydration). One the urine has been tested it will be discarded. No biological samples will be retained. A brief instruction on the different tests of nervous system function ("Valsalva maneuver") and movement patterns (see below) will occur.
Participants will then be asked to lie down on a standard hospital style examination bed. The investigators will then attach the following CSA approved cardiovascular monitoring (all monitors are non-invasive and painless):
Once the monitors are in place, participants will be asked to perform two Valsalva manoeuvres, which is a test of parasympathetic and sympathetic control of the circulatory system and cardiac baroreflex function. During this test, participants will blow out against a closed tube to produce a Valsalva strain (performed as though they were blowing up a balloon that would not inflate, generating a pressure of 40mmHg) and sustain this for 20 seconds. The tube will be connected to a manometer (provides a pressure reading) so the participant can regulate their expiratory pressure. The participant will perform one Valsalva maneuver while lying supine, and a second while sitting upright. Responses will be monitored continuously using the equipment mentioned above.
Next, the participants will complete a 5-minute supine rest period, after which they will be asked to rise from the supine to the standing position and stand on the force platform while we record their cardiovascular and cerebrovascular responses for 5 minutes. Volunteers will stand without shoes, and will be asked not to move their feet for the duration of each standing trial. Following this, volunteers will perform four more bouts of a 5-minute supine period, followed by a 5-minute standing period on the force platform. During each of these trials, they will perform one of the following movements:
These standing trials will be completed in a randomized order. Following their completion, testing will be concluded. The monitoring equipment will be removed and any residue from the ultrasound gel will be wiped away by the participant.
Testing will stop if the volunteer experiences symptoms of presyncope, decreased blood pressure (\<80mmHg systolic pressure for greater than 5 consecutive heart beats), slowing of the heart rate (new onset bradycardia below 50bpm), or at the participant's request. In such an instance the participant will be asked to lie flat until any symptoms or signs of presyncope resolve. If participants meet criteria to stop testing during one of the standing phases, but haven't yet finished all standing phases, they can decide if they want to try the next standing phase, or stop testing all together.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Counterpressure maneuver (CPM) trials will be performed in front of a neutral wall in silence to ensure that visual or auditory stimuli do not affect movement. CPM: * Leg crossing and muscle tensing: Legs are crossed while upright and lower body musculature is isometrically contracted (clinical) * Crouching: Participant crouches down resting weight on the balls of their feet, pressing calves against the back surface of the thighs (clinical) * Exaggerated anterior-posterior sway: Participant sways back and forth with feet planted on ground at a pace/amplitude that is comfortable (discrete) * Gluteal clenching: Participant rhythmically tenses and relaxes the gluteal muscles at a pace/duration that is comfortable (discrete) Participants serve as their own controls and complete both testing arms.
Behavioral: Counterpressure Maneuvers · Behavioral: Baseline Stand
Participants will perform a sit-stand test, followed by 5-minutes of baseline (quiet) standing trial on a force platform while cardiorespiratory responses are recorded. Sit-stand test: following 5-minutes of supine rest, the participant will be passively moved into the seated position. They will then be asked to actively move into the standing position. Baseline stand: immediately following the sit-stand test, the baseline trial will begin. Participants will stand quietly on the force platform for 5-minutes. This trial will be performed in front of a neutral wall in silence to ensure that visual or auditory stimuli do not affect their movement. Participants serve as their own controls and complete both testing arms.
Behavioral: Counterpressure Maneuvers · Behavioral: Baseline Stand
Movements that can aid in delaying or preventing syncope by recruiting skeletal muscle pumping (via compression of major veins by contracting muscle to eject blood through cardiovascular circuit) and increased sympathetic drive (via sustaining an isometric muscle contraction). In this trial, we will be evaluating two clinically recommended isometric maneuvers (crouching, and leg crossing with muscle tensing) and two novel dynamic maneuvers that comprise discrete movement that the investigators have identified in prior work (exaggerated anterior-posterior postural sway, rhythmic gluteal clenching).
Also known as: Physical counter maneuvers, counter maneuvers,
Participants will stand quietly for 5-minutes on a force platform to allow the investigators to assess their typical response to orthostasis.
Also known as: Quiet standing
Relationship between postural movement and stroke volume
We will correlate these two parameters using both time and frequency domain approaches. We will compare this between the five movement conditions using a one-way repeated measures ANOVA.
Time frame: Final minute of maneuver performance
Relationship between anthropometry and response magnitude
We will evaluate the relationship between responses to the CPM and factors of muscle mass and height. We will evaluate this using correlation, regression, and AIC analyses.
Time frame: Final minute of maneuver performance
Relationship between tanner stage and response magnitude
We will compare responses across tanner stages using a 2-way repeated measures ANOVA. We will also consider sex differences in cardiovascular responses to the maneuver, again using a 2-way repeated measures ANOVA
Time frame: Final minute of maneuver performance
Relationship between autonomic control and response magnitude
We will use responses to the Valsalva maneuver and sit-stand test to determine participant autonomic control. Relationships between autonomic control will be evaluated using correlation/regression/AIC analyses. Comparisons between syncopal diagnoses will be made using a 2-way Repeated Measures ANOVA
Time frame: Final minute of maneuver performance, response to maneuver release.
Plan to share: No
Started Apr 2023 (actual). Primary completion is estimated for May 2027, 49 months after the start.
Of 29 interventional studies with no phase under Syncope, Vasovagal, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15. This study's planned 49 months is above that.
How these figures are worked out, and which studies are left out of them.
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Simon Fraser University