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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00962728
Enrollment
30
Registered
2009-08-20
Start date
2009-07-31
Completion date
2026-12-31
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postural Orthostatic Tachycardia Syndrome, Postural Tachycardia Syndrome

Keywords

heart rate, tachycardia, orthostatic intolerance

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.

Interventions

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

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

Sponsors

Vanderbilt University Medical Center
CollaboratorOTHER
Alfredo Gamboa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Magnitude of orthostatic heart rate increase on upright posture10 min

Secondary

MeasureTime frame
Symptoms rating with upright posture10 min
Hemodynamic changes on upright posture10 min

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026