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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new breathing device, the Inspiratory Threshold Device (Res-Q-Gard ITD), to assist individuals with postural tachycardia syndrome (POTS), a condition where heart rate increases upon standing. Researchers aim to determine if this device can help users remain upright longer and prevent heart rate spikes. Participants will use either the real device or a sham (fake) device to compare effects. Suitable candidates have a POTS diagnosis, experience increased heart rate when standing, and have symptoms that worsen in an upright position. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the quality of life for POTS patients.

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.

What prior data suggests that this breathing device is safe for patients with POTS?

Research shows that the Res-Q-Gard Inspiratory Threshold Device (ITD) can help control heart rate in people with postural tachycardia syndrome (POTS) when they stand up. The device increases blood flow and manages heart rate by making it slightly harder to breathe in.

Limited information exists on the device's safety specifically for POTS. However, studies in other contexts have shown that the Res-Q-Gard can safely raise low blood pressure. The overall safety of the device for POTS remains unconfirmed.

Prospective trial participants should know that the device aims to improve blood flow and heart rate. As with any medical device, understanding potential risks and discussing them with the researchers is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Inspiratory Threshold Device (Res-Q-Gard ITD) for POTS because it offers a unique approach to managing this condition. Unlike traditional treatments that often involve medications to regulate heart rate and blood pressure, this device uses a new technique by creating slight resistance during breathing. This resistance may help improve blood flow and stabilize symptoms by training the body to manage blood pressure better. It's a fresh, non-invasive strategy that could provide relief without the side effects associated with medication.

What evidence suggests that this breathing device is effective for POTS?

Research has shown that a special breathing device called an Inspiratory Threshold Device (ITD) can assist people with postural tachycardia syndrome (POTS). In this trial, participants will use either the ITD or a sham device. Previous studies demonstrated that the ITD lowered heart rate and improved blood flow compared to a sham device. For instance, after 10 minutes, individuals using the ITD had a heart rate of 102 beats per minute, while those with the sham device had a heart rate of 109 beats per minute. This suggests that the ITD can help manage heart rate in POTS patients, making it easier for them to stand without issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Satish R Raj, MD MSCI

Principal Investigator

Vanderbilt University School of Medicine

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4472504/

Inspiratory Resistance Improves Postural Tachycardia During orthostatic stress, the ITD effectively reduced heart rate and increased stroke volume during in POTS patients when compared with the sham device.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00962728

Breathing Device in Postural Orthostatic Tachycardia ... The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease heart rate increases ...

3. ahajournals.org ahajournals.org/doi/pdf/10.1161/circep.114.002605

Inspiratory Resistance Improves Postural Tachycardia Background—The objective of this study was to determine the effect of inspiratory resistance through an impedance threshold device (ITD) on orthostatic ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25792354/

Inspiratory resistance improves postural tachycardia - PubMed These findings suggest that increasing negative intrathoracic pressure with ITD breathing improves heart rate control in patients with postural tachycardia ...

5. researchgate.net researchgate.net/publication/273778917_Inspiratory_Resistance_Improves_Postural_Tachycardia_A_Randomized_Study

Inspiratory Resistance Improves Postural Tachycardia After 10 minutes of HUT, the heart rate was lower with the ITD versus sham device (102±4 versus 109±4 beat/min, respectively; p=0.003). The ITD ...

6. withpower.com withpower.com/trial/phase-postural-orthostatic-tachycardia-syndrome-9-2009-9fd04

Breathing Device for POTS · Info for Participants 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 ...

7. zoll.com zoll.com/en-us/education-and-resources/-/media/legacymedia/uploadedfiles/public_site/products/ipr-therapy/resqgard/en/490526000%2003%20resqgard%20sample%20protocol

RESQGARD IMPEDANCE THRESHOLD DEVICE (ITD) ... The safety and effectiveness of the ResQGARD in this clinical setting has not been established. 2. Children under 25 lbs may not be cooperative enough to ...

8. resqpod.com.au resqpod.com.au/resqgard.htm

ResQGARD impedance threshold device - ResQpod Animal and clinical studies have shown that the ResQGARD increases blood pressure during hypotension from a variety of causes, for example: Orthostatic ...