https://clinicaltrials.gov/ct2/show/NCT00962728
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 : January 10, 2019
Sponsor:
Alfredo Gamboa
Collaborator:
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Alfredo Gamboa, Vanderbilt University Medical Center
Study Details Tabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
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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
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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 2019
Estimated Study Completion Date : December 2019
Arms and Interventions
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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
Phase N/A
