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Breathing Device for Orthostatic Hypotension (OH)

Primary Purpose

Orthostatic Hypotension

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory Threshold Device (Res-Q-Gard ITD)
Sham Inspiratory Threshold Device
Sponsored by
Alfredo Gamboa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthostatic Hypotension focused on measuring Orthostatic hypotension, Breathing, Blood pressure, standing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ITD breathing device

Sham Device

Arm Description

Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.

Breathing device similar to active Res-Q-Gard device but with one-way resistance valve removed.

Outcomes

Primary Outcome Measures

Magnitude of drop in Systolic Blood Pressure during head-up tilt

Secondary Outcome Measures

"Standing Time" tolerated with systolic blood pressure above 70 mmHg
Symptom rating
Hemodynamics (non-invasive)

Full Information

First Posted
August 18, 2009
Last Updated
November 13, 2021
Sponsor
Alfredo Gamboa
Collaborators
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00962884
Brief Title
Breathing Device for Orthostatic Hypotension (OH)
Official Title
Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Neurogenic Orthostatic Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No volunteers were enrolled, study was closed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alfredo Gamboa
Collaborators
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension
Keywords
Orthostatic hypotension, Breathing, Blood pressure, standing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ITD breathing device
Arm Type
Experimental
Arm Description
Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.
Arm Title
Sham Device
Arm Type
Sham Comparator
Arm Description
Breathing device similar to active Res-Q-Gard device but with one-way resistance valve removed.
Intervention Type
Device
Intervention Name(s)
Inspiratory Threshold Device (Res-Q-Gard ITD)
Other Intervention Name(s)
Res-Q-Gard ITD device 7.0 (Ref:12-0463-000)
Intervention Description
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
Intervention Type
Device
Intervention Name(s)
Sham Inspiratory Threshold Device
Other Intervention Name(s)
Res-Q-Gard device 7.0 (with active valve removed)
Intervention Description
Breathing through device similar to active device but with the one-way threshold valve removed.
Primary Outcome Measure Information:
Title
Magnitude of drop in Systolic Blood Pressure during head-up tilt
Time Frame
1 min
Secondary Outcome Measure Information:
Title
"Standing Time" tolerated with systolic blood pressure above 70 mmHg
Time Frame
10 min (max)
Title
Symptom rating
Time Frame
10 min (max)
Title
Hemodynamics (non-invasive)
Time Frame
10 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish R Raj, MD MSCI
Organizational Affiliation
Vanderbilt University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17334239
Citation
Convertino VA, Ryan KL, Rickards CA, Cooke WH, Idris AH, Metzger A, Holcomb JB, Adams BD, Lurie KG. Inspiratory resistance maintains arterial pressure during central hypovolemia: implications for treatment of patients with severe hemorrhage. Crit Care Med. 2007 Apr;35(4):1145-52. doi: 10.1097/01.CCM.0000259464.83188.2C.
Results Reference
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PubMed Identifier
15864634
Citation
Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.
Results Reference
background
PubMed Identifier
17976425
Citation
Shibao C, Grijalva CG, Raj SR, Biaggioni I, Griffin MR. Orthostatic hypotension-related hospitalizations in the United States. Am J Med. 2007 Nov;120(11):975-80. doi: 10.1016/j.amjmed.2007.05.009.
Results Reference
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Links:
URL
https://www.vumc.org/autonomic-dysfunction-center/vanderbilt-autonomic-dysfunction
Description
Vanderbilt Autonomic Dysfunction Center Website

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Breathing Device for Orthostatic Hypotension (OH)

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