Controlled Breathing for POTS

Overseen By Shaun Ranada, BSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Somatization, Severe anxiety, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether controlling carbon dioxide (CO2) levels can help manage symptoms of postural orthostatic tachycardia syndrome (POTS), a condition that causes a rapid heartbeat when standing. The researchers aim to find the optimal CO2 level to lower heart rate and improve symptoms. Participants will use the RespirAct™ system, a device that adjusts CO2 levels. This trial suits individuals diagnosed with POTS who do not smoke and can travel to the University of Calgary. As an unphased trial, it offers a unique opportunity for patients to contribute to innovative research that could lead to new strategies for managing POTS symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team for clarification.

What prior data suggests that the RespirAct™ system is safe for use in this study?

Research shows that the RespirAct™ system is under study for its potential to manage symptoms of postural orthostatic tachycardia syndrome (POTS). This system aims to control breathing, which might influence heart rate and other symptoms when standing up.

Previous studies have examined similar breathing devices to assess their effectiveness for POTS. These studies suggest that patients generally tolerate these devices well. Reports of serious side effects from using these devices for POTS have not emerged. However, as with any new treatment, individual experiences may vary.

Overall, while more research is needed to fully understand its effects, early findings suggest that the RespirAct™ system could be a safe option for managing POTS symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RespirAct™ system for POTS (Postural Orthostatic Tachycardia Syndrome) because it offers a non-drug approach to managing symptoms through controlled breathing techniques. Unlike standard treatments, which often involve medications like beta-blockers or fludrocortisone to manage heart rate and blood pressure, the RespirAct™ system utilizes precise control of breathing to potentially stabilize autonomic function. This innovative method could reduce reliance on medication and provide a natural way to improve quality of life for POTS patients.

What evidence suggests that the RespirAct™ system is effective for POTS?

Research shows that controlled breathing can help manage symptoms of postural orthostatic tachycardia syndrome (POTS). Studies have found that altering breathing to increase carbon dioxide (CO2) levels can lower heart rate and improve symptoms when standing. In this trial, all participants will use the RespirAct™ system, designed to manage CO2 levels in the body. This approach might calm the nervous system and alleviate POTS symptoms. The method relies on the idea that CO2 influences nervous system reactions, potentially making it an effective treatment for POTS. Early results suggest this approach could be beneficial, but further research is needed to determine the optimal CO2 level. ^{1 4 6 7 8}

Who Is on the Research Team?

Satish R Raj, MD, MSCI

Principal Investigator

University of Calgary, Cardiac Science

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with a physician's diagnosis of Postural Tachycardia Syndrome (POTS) who can visit the University of Calgary and are non-smokers. Pregnant individuals, those needing portable oxygen, or with severe heart/lung disease, anxiety disorders, or poor past study compliance cannot participate.

Inclusion Criteria

Able and willing to provide informed consent

I have been diagnosed with POTS by a doctor.

I am either male or female.

Exclusion Criteria

I need portable oxygen for breathing, either at rest or during physical activity.

I cannot climb stairs without feeling short of breath due to heart or lung problems.

I have a rapid heartbeat when standing up due to severe dehydration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo hypercapnia intervention using the RespirAct™ system to assess effects on heart rate and orthostatic tolerance

8 weeks

Weekly visits for intervention and monitoring

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RespirAct™ system

Trial Overview The study tests if controlled breathing using the RespirAct™ system to increase CO2 levels can reduce rapid heartbeat and improve symptoms in POTS patients when standing. The goal is to find the best CO2 level for symptom relief.

How Is the Trial Designed?

Group I: All participants Experimental Treatment 1 Intervention

All participants will receive the same interventions

RespirAct™ system is already approved in Canada for the following indications:

Approved in Canada as RespirAct system for:

• Research use in controlling blood gas concentrations for conditions like Postural Orthostatic Tachycardia Syndrome (POTS)

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

The newly developed electronically controlled respirator uses a combination of a positive-pressure ventilator, a recorder pen motor, and a differential amplifier to provide precise control of tracheal pressure in anesthetized cats and dogs.

This servo respirator can operate in two modes: as an externally controlled pump for customizable ventilation parameters or as a 'demand' respirator that adjusts pressure based on the animal's respiratory needs, enhancing its adaptability for veterinary use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Servo respirator constructed from a positive-pressure ventilator. Remmers, JE., Gautier, H.[2017]

Controlled respiration was used as a treatment for 20 patients with complicated myocardial infarction, particularly for severe conditions like shock and pulmonary edema, indicating its potential efficacy in critical situations.

The study found a correlation between clinical outcomes and levels of hypoxemia, suggesting that improving oxygen levels through controlled respiration can be crucial for patients with dangerously low oxygen saturation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of respirators in patients with complicated myocardial infarction. Luczak, J., Dziegielewski, T., Drobnik, L., et al.[2016]

The PACO2 feedback control system for diaphragm pacing successfully maintained normal blood gas levels and pH in research animals for up to 15 hours, indicating its efficacy in respiratory management.

This system also reduced the current applied to the nerve compared to traditional asynchronous pacing, which may help minimize muscle fatigue during prolonged use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A demand diaphragm pacemaker. Satoh, I., Hogan, JF., Glenn, WW., et al.[2019]

In a study of 41 patients with obstructive sleep apnea syndrome (OSAS), the optimal CPAP titration pressure was found to be a median of 9 mmH2O, indicating a standard pressure for effective treatment.

Factors such as larger neck and waist circumferences, along with higher scores for hypopharyngeal collapse and retropalatal/retrolingual wall collapse, were significant predictors of higher CPAP pressures needed for effective therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Affecting Optimal Titration Pressure of Continuous Positive Airway Pressure Device in Patients with Obstructive Sleep Apnea Syndrome. Kırgezen, T., Bilici, S., Çakır, M., et al.[2022]

A closed-loop control system for mechanical ventilation was developed to maintain optimal levels of oxygen and pressure in patients with Adult Respiratory Distress Syndrome (ARDS), using a continuous arterial oxygenation sensor and a computer-controlled ventilator.

In a small clinical trial, this system successfully managed patient therapy 84% of the time, demonstrating its reliability and safety in adjusting ventilation parameters to meet patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A closed-loop controller for mechanical ventilation of patients with ARDS. Anderson, JR., East, TD.[2020]

A new portable device for respiratory revival has been developed, offering better control over gas flow and oxygen delivery compared to traditional auto-inflating reanimation purses.

This device allows operators to adjust peak inspiratory pressure, positive end-expiratory pressure, and both inspiratory and expiratory times, enhancing the effectiveness of resuscitation efforts using either an endotracheal tube or a mask.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[CFR - Continuous Flow Reviver - a new device for respiratory resuscitation]. Resende, JG.[2020]

A new computerized ventilator system effectively adjusts minute volume based on end-tidal CO2 fraction (FETCO2), achieving set-point stabilization in under 60 seconds with minimal overshoot (less than 20%).

The system demonstrated improved stability in FETCO2 levels during controlled ventilation compared to constant minute volume ventilation, indicating its potential for better management of CO2 levels in anesthetized patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feedback controller for ventilatory therapy. Chapman, FW., Newell, JC., Roy, RJ.[2019]

The first ANS controlled rate adaptive pacemaker has been shown to effectively restore a closed loop control system in patients with chronotropic insufficiency, helping to maintain stable blood pressure during varying physical demands.

In a study involving over 200 patients, the pacemaker utilized intracardiac impedance measurements to assess myocardial contractility, providing valuable physiological data for optimizing heart rate adaptation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Measuring intracardiac impedance for the determination of sympathetic nerve activity in frequency-adapted electrostimulation--Part 2: Clinical results]. Pichlmaier, AM., Braile, D., Ebner, E., et al.[2019]

The Bain system for anesthesia allows for controlled respiration and effectively prevents re-inhalation of gases by administering a fresh flow of 70 ml per kg of body weight per minute, which is crucial for maintaining optimal gas exchange.

This system provides optimal control of carbon dioxide levels (PaCO2) through simple adjustments in gas flow, making it a versatile and economical choice in anesthetic practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Bain circuit. Theoretical aspects and clinical use]. Litarczek, G., Tulbure, D., Simionescu, R., et al.[2006]

The OxyGenie controller was more effective than the CLiO2 controller in maintaining oxygen saturation within the target range (91%-95%) for preterm infants, achieving 80.2% of the time compared to 68.5% with CLiO2.

While OxyGenie reduced the time spent above the target range, it resulted in a slight increase in mild hypoxaemia, indicating a trade-off between preventing hyperoxaemia and allowing for some mild hypoxaemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial. Salverda, HH., Cramer, SJE., Witlox, RSGM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00962728

Breathing Device in Postural Orthostatic Tachycardia ... In this pilot study, we will test the hypothesis that breathing through an inspiratory resistance device will improve orthostatic tolerance and reduce ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8562237/

Postural orthostatic tachycardia syndrome: A respiratory ... Respiratory data are shown for 16 subjects with POTS who complained of orthostatic dyspnea; 7 patients diagnosed with recurrent complaints of upright ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2452302X24001840

Clinical Reduced Stroke Volume and Brain Perfusion Drive ... This study challenges current hypotheses by revealing that exaggerated peripheral chemoreceptor activity is not the primary driver of postural hyperventilation.

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.033485

Long‐Term POTS Outcomes Survey: Diagnosis, Therapy ... The LT‐POTS (Long Term POTS Outcomes Survey) included questions about quality of life, symptoms, therapies, education, employment, and social impact of disease.

5. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/postural-orthostatic-tachycardia-syndrome

Postural Orthostatic Tachycardia Syndrome Clinical Trials The aims of this study will be to measure changes in postural orthostatic tachycardia syndrome (POTS) symptoms, functional disability and catastrophizing.

6. jacc.org jacc.org/doi/10.1016/j.jacbts.2024.04.011

Reduced Stroke Volume and Brain Perfusion Drive ... This study challenges current hypotheses by revealing that exaggerated peripheral chemoreceptor activity is not the primary driver of postural hyperventilation.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04271878/hypercapnia-and-orthostatic-tolerance-in-postural-orthostatic-tachycardia-syndrome

Hypercapnia and Orthostatic Tolerance in Postural ... The mechanism behind postural orthostatic tachycardia syndrome (POTS) involves many causes including a sympathetic nervous system problem.

8. clinicaltrial.be clinicaltrial.be/en/details/13309?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Breathing Device in Postural Orthostatic Tachycardia Synd... In this pilot study, we will test the hypothesis that breathing through an inspiratory resistance device will improve orthostatic tolerance and ...