Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)
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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 |
- Magnitude of orthostatic heart rate increase on upright posture [ Time Frame: 10 min ] [ Designated as safety issue: No ]
- 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00962728
| Contact: Satish R Raj, MD MSCI | adcresearch@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: Satish R Raj, MD MSCI | |
| 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: | December 18, 2014 |
| 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 February 25, 2015