Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)
Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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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Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
Other Names:
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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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Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Magnitude of orthostatic heart rate increase on upright posture
Time Frame: 10 min
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10 min
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Symptoms rating with upright posture
Time Frame: 10 min
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10 min
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Hemodynamic changes on upright posture
Time Frame: 10 min
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10 min
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Satish R Raj, MD MSCI, Vanderbilt University School of Medicine
Publications and helpful links
General Publications
- Convertino VA, Ryan KL, Rickards CA, Cooke WH, Idris AH, Metzger A, Holcomb JB, Adams BD, Lurie KG. Inspiratory resistance maintains arterial pressure during central hypovolemia: implications for treatment of patients with severe hemorrhage. Crit Care Med. 2007 Apr;35(4):1145-52. doi: 10.1097/01.CCM.0000259464.83188.2C.
- Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.
- Gamboa A, Paranjape SY, Black BK, Arnold AC, Figueroa R, Okamoto LE, Nwazue VC, Diedrich A, Plummer WD, Dupont WD, Robertson D, Raj SR. Inspiratory resistance improves postural tachycardia: a randomized study. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):651-8. doi: 10.1161/CIRCEP.114.002605. Epub 2015 Mar 19.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiac Conduction System Disease
- Neurologic Manifestations
- Nervous System Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Arrhythmias, Cardiac
- Primary Dysautonomias
- Autonomic Nervous System Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Tachycardia
- Orthostatic Intolerance
- Postural Orthostatic Tachycardia Syndrome
Other Study ID Numbers
- 090609
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