Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

Postural Tachycardia Syndrome Clinical Trial

Official title:

Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00962728
• Other study ID #: 090609
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2009
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Device:
• Inspiratory Threshold Device (Res-Q-Gard ITD)
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
• Sham Inspiratory Threshold Device
Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Alfredo Gamboa	Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of orthostatic heart rate increase on upright posture		10 min
Secondary	Symptoms rating with upright posture		10 min
Secondary	Hemodynamic changes on upright posture		10 min

External Links

•   Vanderbilt Autonomic Dysfunction Center