Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

NCT ID: NCT00962728

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2026-12-31

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.

Conditions

Postural Tachycardia Syndrome; Postural Orthostatic Tachycardia Syndrome

Keywords

heart rate; tachycardia; orthostatic intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

ITD breathing device

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

Group Type: EXPERIMENTAL

Inspiratory Threshold Device (Res-Q-Gard ITD)

Intervention Type: DEVICE

Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.

Sham Device

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

Group Type: SHAM_COMPARATOR

Sham Inspiratory Threshold Device

Intervention Type: DEVICE

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

Interventions

Inspiratory Threshold Device (Res-Q-Gard ITD)

Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.

Intervention Type: DEVICE

Sham Inspiratory Threshold Device

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

Intervention Type: DEVICE

Other Intervention Names

Res-Q-Gard ITD device 7.0 (Ref:12-0463-000); Model 002850P, Sims Portex Inc, Keene NH

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

Alfredo Gamboa

OTHER

Sponsor Role: lead

Responsible Party

Alfredo Gamboa

Research Assistant Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Satish R Raj, MD MSCI

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Medicine

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17334239 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15864634 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25792354 (View on PubMed)

Related Links

https://www.vumc.org/autonomic-dysfunction-center/vanderbilt-autonomic-dysfunction

Vanderbilt Autonomic Dysfunction Center

Other Identifiers

090609

Identifier Type: -

Identifier Source: org_study_id