Breathing Device for POTS

Recruiting in Palo Alto (17 mi)

Overseen by Satish R Raj, MD MSCI

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Alfredo Gamboa

No Placebo Group

Trial Summary

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.

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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vanderbilt University Medical Center Nashville, TN

Who Is Running the Clinical Trial?

Alfredo Gamboa Lead Sponsor

Vanderbilt University Medical Center Collaborator

References