Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2010-12-31
2022-12-31
Brief Summary
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Detailed Description
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Orthostatic hypotension is defined as a fall in systolic blood pressure of at least 20 mmHg within 3 minutes upon standing 3. Patients with orthostatic hypotension commonly experience lightheadedness or syncope. In normal individuals, changes in posture do not results in significant changes in blood pressure due to physiological compensation for the gravity-mediated pooling of blood in the lower limbs with upright posture. Unfortunately, in patients with impairments of the autonomic nervous system, one or more of these adaptive mechanisms fail, and an orthostatic fall in blood pressure results.
In this pilot study, we will test the hypothesis that breathing through an inspiratory resistance device will improve orthostatic tolerance and reduce orthostatic hypotension in patients with neurogenic orthostatic hypotension.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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ITD breathing device
Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.
Inspiratory Threshold Device (Res-Q-Gard ITD)
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
Sham Device
Breathing device similar to active Res-Q-Gard device but with one-way resistance valve removed.
Sham Inspiratory Threshold Device
Breathing through device similar to active device but with the one-way threshold valve removed.
Interventions
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Inspiratory Threshold Device (Res-Q-Gard ITD)
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
Sham Inspiratory Threshold Device
Breathing through device similar to active device but with the one-way threshold valve removed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Decrease in systolic blood pressure ≥ 20 mmHg with position change from supine to standing (10 minutes)
* Evidence of reproducibility suggestive of non-reversible nervous system origin for the orthostatic hypotension
* Age between 18-80 years
* Male and female subjects are eligible
* Able and willing to provide informed consent
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Alfredo Gamboa
OTHER
Responsible Party
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Alfredo Gamboa
Research Assistant Professor of Medicine
Principal Investigators
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Satish R Raj, MD MSCI
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University School of Medicine
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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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. doi: 10.1097/01.CCM.0000259464.83188.2C.
Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.
Shibao C, Grijalva CG, Raj SR, Biaggioni I, Griffin MR. Orthostatic hypotension-related hospitalizations in the United States. Am J Med. 2007 Nov;120(11):975-80. doi: 10.1016/j.amjmed.2007.05.009.
Related Links
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Vanderbilt Autonomic Dysfunction Center Website
Other Identifiers
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090600
Identifier Type: -
Identifier Source: org_study_id