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

Trial Summary

What is the purpose of 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

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 data supports the effectiveness of the RespirAct™ system treatment for POTS?

The effectiveness of the RespirAct™ system may be indirectly supported by research on feedback control systems used in ventilatory therapy, which have shown the ability to maintain stable levels of carbon dioxide in the blood. This suggests that similar feedback mechanisms in the RespirAct™ system could help manage symptoms in POTS by stabilizing breathing patterns. ^{1 2 3 4 5}

How is the RespirAct™ system treatment for POTS different from other treatments?

The RespirAct™ system is unique because it uses controlled breathing to manage POTS, which is different from typical drug-based treatments. This system allows precise control of breathing parameters, potentially improving blood flow and oxygen levels without medication. ^{6 7 8 9 10}

Research Team

Satish R Raj, MD, MSCI

Principal Investigator

University of Calgary, Cardiac Science

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A demand diaphragm pacemaker. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A feedback controller for ventilatory therapy. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Measuring intracardiac impedance for the determination of sympathetic nerve activity in frequency-adapted electrostimulation--Part 2: Clinical results]. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial. [2022]

5. Turkey pubmed.ncbi.nlm.nih.gov

Factors Affecting Optimal Titration Pressure of Continuous Positive Airway Pressure Device in Patients with Obstructive Sleep Apnea Syndrome. [2022]

6. Romania pubmed.ncbi.nlm.nih.gov

[The Bain circuit. Theoretical aspects and clinical use]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Servo respirator constructed from a positive-pressure ventilator. [2017]

8. Poland pubmed.ncbi.nlm.nih.gov

The use of respirators in patients with complicated myocardial infarction. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

A closed-loop controller for mechanical ventilation of patients with ARDS. [2020]

10. Brazil pubmed.ncbi.nlm.nih.gov

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