Clinical Trial: Breathing Device for Orthostatic Hypotension (OH)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Neurogenic Orthostatic Hypotension
Brief Summary: The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease blood pressure drops on standing in patients with orthostatic hypotension.
Detailed Summary:
Orthostatic hypotension is commonly described, especially in an elderly population. Using data from a national hospital inpatient database, Shibao et al. have reported that the annual hospitalization rate for orthostatic hypotension was 233 per 100000 among patients older than 75 years. Orthostatic hypotension is associated with an increased risk of falls, increased risk of coronary heart disease and mortality.
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.
Sponsor: Alfredo Gamboa
Current Primary Outcome: Magnitude of drop in Systolic Blood Pressure during head-up tilt [ Time Frame: 1 min ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- "Standing Time" tolerated with systolic blood pressure above 70 mmHg [ Time Frame: 10 min (max) ]
- Symptom rating [ Time Frame: 10 min (max) ]
- Hemodynamics (non-invasive) [ Time Frame: 10 min ]
Original Secondary Outcome: Same as current
Information By: Vanderbilt University Medical Center
Dates:
Date Received: August 18, 2009
Date Started: December 2010
Date Completion: December 2019
Last Updated: January 10, 2017
Last Verified: January 2017
