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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 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.

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.

Find a Location

Who is running the clinical trial?

Alfredo GamboaLead Sponsor
1 Previous Clinical Trials
Vanderbilt University Medical CenterOTHER
903 Previous Clinical Trials
938,546 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
900 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Satish R Raj, MD MSCIPrincipal InvestigatorVanderbilt University School of Medicine
19 Previous Clinical Trials
1,396 Total Patients Enrolled
7 Trials studying Postural Orthostatic Tachycardia Syndrome
577 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

Media Library

Inspiratory Threshold Device (Res-Q-Gard ITD) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00962728 — N/A
Postural Orthostatic Tachycardia Syndrome Research Study Groups: ITD breathing device, Sham Device
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Inspiratory Threshold Device (Res-Q-Gard ITD) Highlights & Side Effects. Trial Name: NCT00962728 — N/A
Inspiratory Threshold Device (Res-Q-Gard ITD) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00962728 — N/A
~2 spots leftby Nov 2025