Breathing Device for Orthostatic Hypotension (OH)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Orthostatic Hypotension |
Device: Inspiratory Threshold Device (Res-Q-Gard ITD) Device: Sham Inspiratory Threshold Device |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) 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 ] [ Designated as safety issue: No ]
- "Standing Time" tolerated with systolic blood pressure above 70 mmHg [ Time Frame: 10 min (max) ] [ Designated as safety issue: No ]
- Symptom rating [ Time Frame: 10 min (max) ] [ Designated as safety issue: No ]
- Hemodynamics (non-invasive) [ Time Frame: 10 min ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ITD beathing 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)
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with neurogenic orthostatic hypotension by the Vanderbilt Autonomic Dysfunction Center
- 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:
- Overt cause for orthostatic hypotension (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
Contacts and Locations| Contact: Bonnie K Black, BSN | adcresearch@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232-2195 | |
| Principal Investigator: Satish R Raj, MD MSCI | |
| Principal Investigator: | Satish R Raj, MD MSCI | Vanderbilt University School of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Satish R. Raj, Assistant Professor of Medicine & Pharmacology, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00962884 History of Changes |
| Other Study ID Numbers: | 090600 |
| Study First Received: | August 18, 2009 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
Orthostatic hypotension Breathing Blood pressure standing |
Additional relevant MeSH terms:
|
Hypotension Hypotension, Orthostatic Orthostatic Intolerance Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Vascular Diseases Cardiovascular Diseases Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013