Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
Vanderbilt University Medical Center
Summary
The objective of this study is to find a more objective and accurate way to assess the efficacy of the treatment for neurogenic orthostatic hypotension. For this purpose, the investigators will use an activity monitor to determine the amount of time patients spend in the upright position (standing and walking; upright time) during 1 week of placebo (a pill with no active ingredients) and 1 week of their regular medication for orthostatic hypotension (midodrine or atomoxetine at their usual doses). Total upright time (i.e. tolerance to standing and walking) will be compared between placebo and active treatment to test the hypothesis that it can be used to assess the efficacy of the treatment for orthostatic hypotension and whether this outcome is superior to the assessment of symptoms using validated questionnaires.
Description
Patients with autonomic failure cannot regulate blood pressure properly. Upon standing, their blood pressure drops (i.e. orthostatic hypotension) and may cause symptoms such as lightheadedness, dizziness, changes in vision, weakness, fatigue, trouble concentrating, and shoulder and neck pain. Orthostatic hypotension can be severe and disabling; it can lead to frequent loss of consciousness and falls. These symptoms can make it difficult to perform activities of daily living resulting in significant impairment of the patient's quality of life. Thus, the assessment of orthostatic symptoms using…
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male and female subjects, age 40-80 years. * Possible or probable Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension. * Neurogenic orthostatic hypotension defined as a ≥ 30 mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes. * Patients on treatment for neurogenic orthostatic hypotension with either midodrine or atomoxetine, who have experienced some improvement in their ort…
Interventions
- DeviceAccelerometer
A uniaxial accelerometer-based activity monitor (ActivpalTM) will be worn by participants on one of the thighs during the 7 days of the placebo and treatment periods.
- Drugplacebo pill
Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.
- DrugMidodrine or atomoxetine pill
Either midodrine or atomoxetine at their regular dose.
Location
- Autonomic Dysfunction Center/ Vanderbilt University Medical CenterNashville, Tennessee