Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

• ClinicalTrials.gov Identifier: NCT00962728
• Recruitment Status: Active, not recruiting
• First Posted: August 20, 2009
• Last Update Posted: September 2, 2020
• Sponsor: Alfredo Gamboa
• Collaborator: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Alfredo Gamboa, Vanderbilt University Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Postural Tachycardia Syndrome; Postural Orthostatic Tachycardia Syndrome	Device: Inspiratory Threshold Device (Res-Q-Gard ITD); Device: Sham Inspiratory Threshold Device	Not Applicable

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: ITD breathing device; Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.	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.	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

Outcome Measures

Primary Outcome Measures :

1. Magnitude of orthostatic heart rate increase on upright posture [ Time Frame: 10 min ]

Secondary Outcome Measures :

1. Symptoms rating with upright posture [ Time Frame: 10 min ]
2. Hemodynamic changes on upright posture [ Time Frame: 10 min ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Alfredo Gamboa

Vanderbilt University Medical Center

Investigators

• Principal Investigator: Satish R Raj, MD MSCI; Vanderbilt University School of Medicine

More Information

Additional Information:

Vanderbilt Autonomic Dysfunction Center 

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.

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. Epub 2005 Apr 28.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: September 2, 2020
• Last Verified: August 2020

Keywords provided by Alfredo Gamboa, Vanderbilt University Medical Center:

heart rate; tachycardia; orthostatic intolerance

Additional relevant MeSH terms:

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