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Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

Primary Purpose

Postural Tachycardia Syndrome, Postural Orthostatic Tachycardia Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory Threshold Device (Res-Q-Gard ITD)
Sham Inspiratory Threshold Device
Sponsored by
Alfredo Gamboa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postural Tachycardia Syndrome focused on measuring heart rate, tachycardia, orthostatic intolerance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ITD breathing device

Sham Device

Arm Description

Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.

Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.

Outcomes

Primary Outcome Measures

Magnitude of orthostatic heart rate increase on upright posture

Secondary Outcome Measures

Symptoms rating with upright posture
Hemodynamic changes on upright posture

Full Information

First Posted
August 18, 2009
Last Updated
August 9, 2023
Sponsor
Alfredo Gamboa
Collaborators
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00962728
Brief Title
Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)
Official Title
Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2009 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alfredo Gamboa
Collaborators
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Tachycardia Syndrome, Postural Orthostatic Tachycardia Syndrome
Keywords
heart rate, tachycardia, orthostatic intolerance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ITD breathing device
Arm Type
Experimental
Arm Description
Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.
Arm Title
Sham Device
Arm Type
Sham Comparator
Arm Description
Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.
Intervention Type
Device
Intervention Name(s)
Inspiratory Threshold Device (Res-Q-Gard ITD)
Other Intervention Name(s)
Res-Q-Gard ITD device 7.0 (Ref:12-0463-000)
Intervention Description
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
Intervention Type
Device
Intervention Name(s)
Sham Inspiratory Threshold Device
Other Intervention Name(s)
Model 002850P, Sims Portex Inc, Keene NH
Intervention Description
Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.
Primary Outcome Measure Information:
Title
Magnitude of orthostatic heart rate increase on upright posture
Time Frame
10 min
Secondary Outcome Measure Information:
Title
Symptoms rating with upright posture
Time Frame
10 min
Title
Hemodynamic changes on upright posture
Time Frame
10 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish R Raj, MD MSCI
Organizational Affiliation
Vanderbilt University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17334239
Citation
Convertino VA, Ryan KL, Rickards CA, Cooke WH, Idris AH, Metzger A, Holcomb JB, Adams BD, Lurie KG. Inspiratory resistance maintains arterial pressure during central hypovolemia: implications for treatment of patients with severe hemorrhage. Crit Care Med. 2007 Apr;35(4):1145-52. doi: 10.1097/01.CCM.0000259464.83188.2C.
Results Reference
background
PubMed Identifier
15864634
Citation
Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.
Results Reference
background
PubMed Identifier
25792354
Citation
Gamboa A, Paranjape SY, Black BK, Arnold AC, Figueroa R, Okamoto LE, Nwazue VC, Diedrich A, Plummer WD, Dupont WD, Robertson D, Raj SR. Inspiratory resistance improves postural tachycardia: a randomized study. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):651-8. doi: 10.1161/CIRCEP.114.002605. Epub 2015 Mar 19.
Results Reference
derived
Links:
URL
https://www.vumc.org/autonomic-dysfunction-center/vanderbilt-autonomic-dysfunction
Description
Vanderbilt Autonomic Dysfunction Center

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Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

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