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Postural Tachycardia Syndrome | Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

Postural Tachycardia Syndrome research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Postural Tachycardia Syndrome

Postural Orthostatic Tachycardia Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Inspiratory Threshold Device (Res-Q-Gard ITD)Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.

Device:Sham Inspiratory Threshold DeviceBreathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Active, not recruiting

Start Date: October 2009

Completed Date: December 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Magnitude of orthostatic heart rate increase on upright posture

Secondary Outcome: Symptoms rating with upright posture

Study sponsors, principal investigator, and references

Principal Investigator: Satish R Raj, MD MSCI

Lead Sponsor: Alfredo Gamboa

Collaborator: Vanderbilt University Medical Center

More information:https://clinicaltrials.gov/show/NCT00962728

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.

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