Breathing Device for Orthostatic Hypotension (OH)
|Orthostatic Hypotension||Device: Inspiratory Threshold Device (Res-Q-Gard ITD) Device: Sham Inspiratory Threshold Device||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Neurogenic Orthostatic Hypotension|
- Magnitude of drop in Systolic Blood Pressure during head-up tilt [ Time Frame: 1 min ]
- "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 ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Experimental: ITD breathing device
Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.
Device: Inspiratory Threshold Device (Res-Q-Gard ITD)
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
Other Name: Res-Q-Gard ITD device 7.0 (Ref:12-0463-000)
Sham Comparator: Sham Device
Breathing device similar to active Res-Q-Gard device but with one-way resistance valve removed.
Device: Sham Inspiratory Threshold Device
Breathing through device similar to active device but with the one-way threshold valve removed.
Other Name: Res-Q-Gard device 7.0 (with active valve removed)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962884
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-2195|
|Principal Investigator:||Satish R Raj, MD MSCI||Vanderbilt University School of Medicine|