What side effects are associated with this type of intervention?

Common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) that enhance respiratory muscle strength and improve venous return, such as inspiratory resistance devices, generally have minimal side effects. However, patients may experience mild discomfort or fatigue in the respiratory muscles initially. Other common treatments for POTS, including medications like beta-blockers, fludrocortisone, and midodrine, can have side effects such as fatigue, headache, high blood pressure, and gastrointestinal issues. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

There are no specific FDA-approved drugs or devices that directly target the enhancement of respiratory muscle strength and venous return for the treatment of Postural Orthostatic Tachycardia Syndrome (POTS). Current management of POTS typically includes non-pharmacologic strategies such as increased fluid and salt intake, compression garments, and physical therapy. Pharmacologic treatments may involve medications like fludrocortisone, midodrine, and beta-blockers to manage symptoms. The inspiratory resistance device being studied represents a novel approach, focusing on improving the ability to be upright and decreasing heart rate increases on standing.

What other types of research exist?

Promising novel alternatives to Inspiratory Resistance Devices for POTS patients include: 1) Physical counter-maneuvers such as leg crossing and muscle tensing to improve venous return, 2) Compression garments to enhance blood flow, 3) Pharmacological treatments like beta-blockers or fludrocortisone to manage heart rate and blood volume, and 4) Tilt training to improve orthostatic tolerance. These alternatives can be discussed with a healthcare provider to determine the best individualized treatment plan.

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Other

Breathing Device for POTS

N/A

Waitlist Available

Led By Satish R Raj, MD MSCI

Research Sponsored by Alfredo Gamboa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence

Be older than 18 years old

Must not have

Overt cause for postural tachycardia (such as acute dehydration)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from using the breathing device, possible lightheadedness or shortness of breath due to increased effort during inhalation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ITD breathing deviceExperimental Treatment1 Intervention

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

Group II: Sham DevicePlacebo Group1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) often focus on improving blood circulation and reducing heart rate increases upon standing. The inspiratory resistance device, for example, works by strengthening respiratory muscles, which can enhance venous return to the heart and stabilize blood pressure. This is crucial for POTS patients as it helps mitigate the excessive heart rate increase and dizziness experienced when standing. Other treatments may include physical maneuvers like leg crossing and squatting, which also promote venous return, and medications such as beta-blockers that help control heart rate. These interventions collectively aim to improve the patient's ability to remain upright without experiencing debilitating symptoms.

Effects of respiratory drive on upper airways in sleep apnea patients and normal subjects.Locked-in Guillain-Barré syndrome: 'my living nightmare'.The effectiveness of combining inspiratory muscle training with manual therapy and a therapeutic exercise program on maximum inspiratory pressure in adults with asthma: a randomized clinical trial.