Actively Recruiting
Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
Led by Vanderbilt University Medical Center · Updated on 2025-06-26
29
Participants Needed
1
Research Sites
347 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects, age 40-80 years.
- Diagnosis of possible or probable Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension.
- Neurogenic orthostatic hypotension defined as a decrease of 30 mmHg or more in systolic blood pressure within 3 minutes of standing with impaired autonomic reflexes and no other causes.
- Currently treated with midodrine or atomoxetine with some symptom improvement but still symptomatic (OHSA score 1 to 5).
- Able to stay with a caregiver during the study.
- Able and willing to provide informed consent.
You will not qualify if you...
- Bedridden, physically disabled, or unable to walk.
- OHSA score 6 or higher, or systolic blood pressure drop of 30 mmHg or more on regular treatment.
- Taking more than one medication for neurogenic orthostatic hypotension (except pyridostigmine or fludrocortisone).
- Pregnant.
- Systemic illnesses causing autonomic neuropathy such as diabetes, amyloidosis, monoclonal gammopathies, or autoimmune neuropathies.
- Clinically unstable coronary artery disease or major cardiovascular or neurological events in the past 6 months.
- Using anticoagulants.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
B
Bonnie K Black, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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