Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)
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ClinicalTrials.gov Identifier: NCT00962728 |
Recruitment Status :
Active, not recruiting
First Posted : August 20, 2009
Last Update Posted : November 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Postural Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome | Device: Inspiratory Threshold Device (Res-Q-Gard ITD) Device: Sham Inspiratory Threshold Device | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome |
Study Start Date : | October 2009 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | December 2023 |
Arm | Intervention/treatment |
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Experimental: ITD breathing device
Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.
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Device: Inspiratory Threshold Device (Res-Q-Gard ITD)
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
Other Name: Res-Q-Gard ITD device 7.0 (Ref:12-0463-000) |
Sham Comparator: Sham Device
Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.
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Device: Sham Inspiratory Threshold Device
Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.
Other Name: Model 002850P, Sims Portex Inc, Keene NH |
- Magnitude of orthostatic heart rate increase on upright posture [ Time Frame: 10 min ]
- Symptoms rating with upright posture [ Time Frame: 10 min ]
- Hemodynamic changes on upright posture [ Time Frame: 10 min ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962728
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Satish R Raj, MD MSCI | Vanderbilt University School of Medicine |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Alfredo Gamboa, Research Assistant Professor of Medicine, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT00962728 |
Other Study ID Numbers: |
090609 |
First Posted: | August 20, 2009 Key Record Dates |
Last Update Posted: | November 22, 2021 |
Last Verified: | November 2021 |
heart rate tachycardia orthostatic intolerance |
Postural Orthostatic Tachycardia Syndrome Tachycardia Syndrome Disease Pathologic Processes Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Cardiac Conduction System Disease Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases |