Breathing Device for Orthostatic Hypotension (OH)

Orthostatic Hypotension Clinical Trial

Official title:

Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Neurogenic Orthostatic Hypotension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00962884
• Other study ID #: 090600
• Status: Withdrawn
• Phase: N/A
• Start date: December 2010
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Respiratory Aspiration

Intervention

Device:
• Inspiratory Threshold Device (Res-Q-Gard ITD)
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
• Sham Inspiratory Threshold Device
Breathing through device similar to active device but with the one-way threshold valve removed.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Alfredo Gamboa	Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Epub 2005 Apr 28. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of drop in Systolic Blood Pressure during head-up tilt		1 min
Secondary	"Standing Time" tolerated with systolic blood pressure above 70 mmHg		10 min (max)
Secondary	Symptom rating		10 min (max)
Secondary	Hemodynamics (non-invasive)		10 min

External Links

•   Vanderbilt Autonomic Dysfunction Center Website