NCT00962728

Breathing Device in Postural Orthostatic Tachycardia Syndrome (POTS)

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Alfredo Gamboa · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2009-07-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2009-08-20
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States