NCT00962884

Breathing Device for Orthostatic Hypotension (OH)

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alfredo Gamboa · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthostatic Hypotension

Interventions

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

Timeline

• Start date: 2010-12-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2009-08-20
• Last updated: 2021-11-22

Locations

1 site across 1 country: United States