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
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.
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.
Active, not recruiting
Start Date: October 2009
Completed Date: December 2019
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
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.