Breathing Device for Orthostatic Hypotension (OH)

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.

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