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Breathing Device for Orthostatic Hypotension (OH)

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ClinicalTrials.gov Identifier: NCT00962884
Recruitment Status : Active, not recruiting
First Posted : August 20, 2009
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Orthostatic Hypotension Device: Inspiratory Threshold Device (Res-Q-Gard ITD) Device: Sham Inspiratory Threshold Device Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : December 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Magnitude of drop in Systolic Blood Pressure during head-up tilt [ Time Frame: 1 min ]

Secondary Outcome Measures :
  1. "Standing Time" tolerated with systolic blood pressure above 70 mmHg [ Time Frame: 10 min (max) ]
  2. Symptom rating [ Time Frame: 10 min (max) ]
  3. Hemodynamics (non-invasive) [ Time Frame: 10 min ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962884


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2195
Sponsors and Collaborators
Alfredo Gamboa
Vanderbilt University Medical Center
Investigators
Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University School of Medicine
More Information

Additional Information:
Publications:
Responsible Party: Alfredo Gamboa, Research Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00962884     History of Changes
Other Study ID Numbers: 090600
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Keywords provided by Alfredo Gamboa, Vanderbilt University Medical Center:
Orthostatic hypotension
Breathing
Blood pressure
standing

Additional relevant MeSH terms:
Respiratory Aspiration
Hypotension
Hypotension, Orthostatic
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases