Breathing Device for Orthostatic Hypotension (OH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Vanderbilt University
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00962884
First received: August 18, 2009
Last updated: January 7, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Magnitude of drop in Systolic Blood Pressure during head-up tilt [ Time Frame: 1 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • "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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962884

Contacts
Contact: Bonnie K Black, BSN adcresearch@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-2195
Principal Investigator: Satish R Raj, MD MSCI         
Sponsors and Collaborators
Satish R. Raj
Vanderbilt University
Investigators
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
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014