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Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962728
First Posted: August 20, 2009
Last Update Posted: January 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Alfredo Gamboa, Vanderbilt University Medical Center
  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
Postural Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome Device: Inspiratory Threshold Device (Res-Q-Gard ITD) Device: Sham Inspiratory Threshold Device

Study Type: Interventional
Study Design: 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

Further study details as provided by Alfredo Gamboa, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Magnitude of orthostatic heart rate increase on upright posture [ Time Frame: 10 min ]

Secondary Outcome Measures:
  • Symptoms rating with upright posture [ Time Frame: 10 min ]
  • Hemodynamic changes on upright posture [ Time Frame: 10 min ]

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 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Information from the National Library of Medicine

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


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:
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     History of Changes
Other Study ID Numbers: 090609
First Submitted: August 18, 2009
First Posted: August 20, 2009
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by Alfredo Gamboa, Vanderbilt University Medical Center:
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