Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Vanderbilt University
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00962728
First received: August 18, 2009
Last updated: January 7, 2013
Last verified: January 2013
  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:


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 2015
Estimated Primary Completion Date: December 2015 (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
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

Contacts
Contact: Satish R Raj, MD MSCI adcresearch@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Satish R Raj, MD MSCI         
Sponsors and Collaborators
Satish R. Raj
Vanderbilt University
Investigators
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00962728     History of Changes
Other Study ID Numbers: 090609
Study First Received: August 18, 2009
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
heart rate
tachycardia
orthostatic intolerance

Additional relevant MeSH terms:
Postural Orthostatic Tachycardia Syndrome
Syndrome
Tachycardia
Arrhythmias, Cardiac
Autonomic Nervous System Diseases
Cardiovascular Diseases
Disease
Heart Diseases
Nervous System Diseases
Orthostatic Intolerance
Pathologic Processes
Primary Dysautonomias

ClinicalTrials.gov processed this record on October 20, 2014