Testing RespirAct™ system (Thornhill Research for postural tachycardia syndrome
Official title: Hypercapnia and Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome
- 1 group
- One site, in Calgary
- Recruiting
Interventions
- Other intervention
RespirAct™ system (Thornhill Research Inc., Toronto, Canada)
1. HUTT with Normal Breathing in Room Air (No gas interventions will be applied) 2. HUTT with Normal Breathing and ETCO2 clamped at baseline levels 3. HUTT with Normal Breathing and Mild Hypercapnia (the ETCO2 will be clamped at 45mmHg ) 4. HUTT with Normal Breathing and High Hypercapnia (the ETCO2 will be clamped at 55mmHg) 5. HUTT with Fast, Deep Breathing and resultant Hypocapnia Participant will be coached to breath around 15 breath per min.No gas interventions will be applied 6. HUTT with Fast, Deep Breathing and ETCO2 clamped at baseline levels. Participant will be coached to breath around 15 breath per min, with ETCO2 clamped to baseline levels.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 18-60 years
- +Physician diagnosis of Postural Tachycardia Syndrome (POTS)
- +Male and Female
- +Able and willing to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Ability to travel to Libin Cardiovascular Institute of Alberta Autonomic Testing Lab at the University of Calgary, Calgary, AB.
- +Non - smokers.
Exclusion
- −Overt cause for postural tachycardia, i.e., acute dehydration
- −Participants with somatization or severe anxiety symptoms will be excluded
- −Inability to tolerate mask for the duration of the study
- −Subjects who require portable oxygen at rest or with exercise
- −Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath.
- −Other factors which in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion would prevent the participant from completing the protocolProtocolThe detailed plan a study must follow.Read more →, including poor compliance during previous studies.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives RespirAct™ system (Thornhill Research Inc., Toronto, Canada).
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 60 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 26 people.
The study is currently expected to finish around December 2030.
The main measurement is taken over: difference between HR from supine to peak HR during tilt test for each intervention (mean value HR between the 8th and 9th minute of supine; peak parameters, during HUTT, mean value during the first min and between the 3rd and 8th min).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Heart Rate (HR) variation — measured over difference between HR from supine to peak HR during tilt test for each intervention (mean value HR between the 8th and 9th minute of supine; peak parameters, during HUTT, mean value during the first min and between the 3rd and 8th min).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04271878 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About RespirAct™ system (Thornhill Research Inc., Toronto, Canada)Other
1. HUTT with Normal Breathing in Room Air (No gas interventions will be applied) 2. HUTT with Normal Breathing and ETCO2 clamped at baseline levels 3. HUTT with Normal Breathing and Mild Hypercapnia (the ETCO2 will be clamped at 45mmHg ) 4. HUTT with Normal Breathing and High Hypercapnia (the ETCO2 will be clamped at 55mmHg) 5. HUTT with Fast, Deep Breathing and resultant Hypocapnia Participant will be coached to breath around 15 breath per min.No gas interventions will be applied 6. HUTT with Fast, Deep Breathing and ETCO2 clamped at baseline levels. Participant will be coached to breath around 15 breath per min, with ETCO2 clamped to baseline levels.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 60 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 60 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: difference between HR from supine to peak HR during tilt test for each intervention (mean value HR between the 8th and 9th minute of supine; peak parameters, during HUTT, mean value during the first min and between the 3rd and 8th min).
The study as a whole is currently expected to finish around 2030-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 26 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Calgary, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The mechanism behind postural orthostatic tachycardia syndrome (POTS) involves many causes including a sympathetic nervous system problem. Blood gases, like carbon dioxide (CO2), have an important effect on sympathetic activation. The purpose of this research study is to determine if higher CO2 levels have any effect in lowering heart rate and reducing POTS symptoms when upright/standing. The investigators are also searching for the ideal CO2 concentration to achieve the most effective response
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.