We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Breathing Device for Orthostatic Hypotension (OH)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962884
First Posted: August 20, 2009
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Alfredo Gamboa, Vanderbilt University Medical Center
  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 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Alfredo Gamboa, Vanderbilt University Medical Center:

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

Secondary Outcome Measures:
  • "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 ]

Estimated Enrollment: 30
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)
Arms Assigned Interventions
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)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: August 18, 2009
First Posted: August 20, 2009
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:
Hypotension
Hypotension, Orthostatic
Orthostatic Intolerance
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases