Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS) - Full Text View

Purpose

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	Intervention	Phase
Postural Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome	Device: Inspiratory Threshold Device (Res-Q-Gard ITD) Device: Sham Inspiratory Threshold Device	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Postural Orthostatic Tachycardia Syndrome

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Magnitude of orthostatic heart rate increase on upright posture [ Time Frame: 10 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptoms rating with upright posture [ Time Frame: 10 min ] [ Designated as safety issue: No ]
Hemodynamic changes on upright posture [ Time Frame: 10 min ] [ Designated as safety issue: No ]


Estimated Enrollment:	30
Study Start Date:	October 2009
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ITD beathing 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

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962728

Locations


United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Alfredo Gamboa

Vanderbilt University

Investigators


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

More Information

Additional Information:

Vanderbilt Autonomic Dysfunction Center This link exits the ClinicalTrials.gov site

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
ClinicalTrials.gov Identifier:	NCT00962728 History of Changes
Other Study ID Numbers:	090609
Study First Received:	August 18, 2009
Last Updated:	April 26, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:


heart rate tachycardia orthostatic intolerance

Additional relevant MeSH terms:


Syndrome Tachycardia Postural Orthostatic Tachycardia Syndrome Disease Pathologic Processes Arrhythmias, Cardiac	Heart Diseases Cardiovascular Diseases Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2016