Overview

This trial is active, not recruiting.

Conditions postural tachycardia syndrome, postural orthostatic tachycardia syndrome
Treatments inspiratory threshold device (res-q-gard itd), sham inspiratory threshold device
Phase phase 2
Sponsor Alfredo Gamboa
Collaborator Vanderbilt University
Start date October 2009
End date December 2017
Trial size 30 participants
Trial identifier NCT00962728, 090609

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.
inspiratory threshold device (res-q-gard itd) Res-Q-Gard ITD device 7.0 (Ref:12-0463-000)
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
(Sham Comparator)
Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.
sham inspiratory threshold device Model 002850P, Sims Portex Inc, Keene NH
Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.

Primary Outcomes

Measure
Magnitude of orthostatic heart rate increase on upright posture
time frame: 10 min

Secondary Outcomes

Measure
Symptoms rating with upright posture
time frame: 10 min
Hemodynamic changes on upright posture
time frame: 10 min

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome
Principal investigator Satish R Raj, MD MSCI
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.