Breathing Device for POTS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alfredo Gamboa

Disqualifiers: Acute dehydration, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

30 Participants Needed

Trial Summary

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 trial coordinators.

How is the Res-Q-Gard ITD treatment for POTS different from other treatments?

The Res-Q-Gard ITD is unique because it uses a breathing device to enhance blood flow by creating negative pressure in the chest, which is different from typical POTS treatments that often involve medication or lifestyle changes. This device has been used in other conditions like cardiac arrest to improve circulation, making it a novel approach for POTS. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests if using a special breathing device can help people with a condition that causes dizziness when they stand up manage their symptoms better.

Research Team

Satish R Raj, MD MSCI

Principal Investigator

Vanderbilt University School of Medicine

Eligibility Criteria

This trial is for individuals diagnosed with POTS by the Vanderbilt Autonomic Dysfunction Center, who experience a heart rate increase of at least 30 beats/min when standing up and have symptoms that improve when lying down. Participants must be able to consent. Pregnant individuals or those unable to complete the study are excluded.

Inclusion Criteria

My symptoms, like dizziness, improve when I lie down.

You have been diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center.

Your heart rate goes up by 30 beats per minute or more when you stand up from lying down.

Exclusion Criteria

Inability to give, or withdrawal of, informed consent

I have a rapid heartbeat when standing up due to a clear reason like dehydration.

Other factors which in the investigator's opinion would prevent the subject from completing the protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either the ITD breathing device or a sham device to test its effects on orthostatic tolerance and heart rate

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Inspiratory Threshold Device (Res-Q-Gard ITD)
• Sham Inspiratory Threshold Device

Trial Overview The study is examining if using an Inspiratory Threshold Device (Res-Q-Gard ITD), which adds resistance to breathing, can help POTS patients stand upright more comfortably and reduce rapid heartbeat upon standing. A sham device serves as a comparison in this experiment.

Participant Groups

Group I: ITD breathing device Experimental Treatment 1 Intervention

Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.

Group II: Sham Device Placebo Group 1 Intervention

Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.

Who Is Running the Clinical Trial?

Alfredo Gamboa

Lead Sponsor

Trials

2

Recruited

30+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

References

1. China pubmed.ncbi.nlm.nih.gov

[Application of the inspiratory impedance threshold device and its research progress]. [2018]

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

Cardiopulmonary effects of a new inspiratory impedance threshold device in anesthetized hypotensive dogs. [2017]

3. Ireland pubmed.ncbi.nlm.nih.gov

Use of an impedance threshold device improves short-term outcomes following out-of-hospital cardiac arrest. [2016]

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

A trial of an impedance threshold device in out-of-hospital cardiac arrest. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Effects of an inspiratory impedance threshold device on blood pressure and short term survival in spontaneously breathing hypovolemic pigs. [2013]