Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT00962728

Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease heart rate increases on standing in patients with postural tachycardia syndrome.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

About this study

Chronic orthostatic intolerance, sometimes known as the postural tachycardia syndrome (POTS), is the most common disorder among patients seen at several centers specializing in diseases of the autonomic nervous system. It affects an estimated 500,000 people in the United States alone. POTS (excessive increase in heart rate [>30 min-1] on standing associated with orthostatic symptoms [including palpitation, chest pain syndrome, dyspnea on standing, mental clouding and difficulties with concentration], in the absence of orthostatic hypotension) can produce substantial disability among otherwise healthy people. Patients with POTS typically feel tired and run down. Many also report a myriad of symptoms that are hard to categorize, often involving fatigue. One study, from the Mayo Clinic, found that patients with POTS had a diminished quality of life when measured using a standard health status instrument (SF-36).

In this pilot study, we will test the hypothesis that breathing through an inspiratory resistance device will improve orthostatic tolerance and reduce orthostatic tachycardia in patients with postural tachycardia syndrome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
  • Increase in heart rate ≥ 30 beats/min with position change from supine to standing (10 minutes)
  • Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
  • Able and willing to provide informed consent

Exclusion criteria

  • Overt cause for postural tachycardia (such as acute dehydration)
  • Inability to give, or withdrawal of, informed consent
  • Pregnant
  • Other factors which in the investigator's opinion would prevent the subject from completing the protocol

Treatment and study plan

Inspiratory Threshold Device (Res-Q-Gard ITD)

Device

Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.

Other names: Res-Q-Gard ITD device 7.0 (Ref:12-0463-000)

Sham Inspiratory Threshold Device

Device

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

Other names: Model 002850P, Sims Portex Inc, Keene NH

Primary outcomes

  1. Magnitude of orthostatic heart rate increase on upright posture

    Time frame: 10 min

Secondary outcomes

  1. Symptoms rating with upright posture

    Time frame: 10 min

  2. Hemodynamic changes on upright posture

    Time frame: 10 min

Sponsors and collaborators

Lead sponsor

Alfredo Gamboa

Other

Collaborators

  • Vanderbilt University Medical Center

Registry information

Official study title

Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome

Important dates

Study start
2009
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2009
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.