IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)
This study is ongoing, but not recruiting participants.
Sponsor:
Alfredo Gamboa
Collaborator:
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Alfredo Gamboa, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00962728
First received: August 18, 2009
Last updated: January 18, 2017
Last verified: January 2017
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: 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| 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
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
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 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 |
| Study First Received: | August 18, 2009 |
| Last Updated: | January 18, 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 |
ClinicalTrials.gov processed this record on July 21, 2017