Overview

This trial is active, not recruiting.

Condition orthostatic hypotension
Treatments inspiratory threshold device (res-q-gard itd), sham inspiratory threshold device
Phase phase 2
Sponsor Alfredo Gamboa
Collaborator Vanderbilt University
Start date December 2010
End date December 2019
Trial size 30 participants
Trial identifier NCT00962884, 090600

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.
inspiratory threshold device (res-q-gard itd) Res-Q-Gard ITD device 7.0 (Ref:12-0463-000)
Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.
(Sham Comparator)
Breathing device similar to active Res-Q-Gard device but with one-way resistance valve removed.
sham inspiratory threshold device Res-Q-Gard device 7.0 (with active valve removed)
Breathing through device similar to active device but with the one-way threshold valve removed.

Primary Outcomes

Measure
Magnitude of drop in Systolic Blood Pressure during head-up tilt
time frame: 1 min

Secondary Outcomes

Measure
"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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Assessment of Inspiratory Breathing Devices to Improve Orthostatic Tolerance in Neurogenic Orthostatic Hypotension
Principal investigator Satish R Raj, MD MSCI
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.