Actively Recruiting
Use of Accelerometer to Measure Symptoms in Neurogenic Orthostatic Hypotension Patients
Led by Vanderbilt University Medical Center · Updated on 2025-06-26
29
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find a more objective and accurate way to assess the effectiveness of treatments for neurogenic orthostatic hypotension, a condition where patients experience a dangerous drop in blood pressure upon standing, causing symptoms like dizziness, weakness, and fatigue. It focuses on patients with autonomic failure who still have symptoms despite treatment with midodrine or atomoxetine. The study evaluates whether measuring upright time using an activity monitor is better than symptom questionnaires at assessing treatment efficacy. Participants will undergo two separate one-week periods at home, wearing an accelerometer on their thigh to track standing and walking time. One week involves taking a placebo pill, and the other involves their regular medication (midodrine or atomoxetine), with a one-week washout period in between. The order of treatments is randomized and blinded. Participants will record daily activity times and complete questionnaires and blood pressure measurements at the end of each week. Throughout the study, researchers will monitor total standing time, walking time, number of steps, and orthostatic symptoms using the activity monitor and questionnaires. Blood pressure will be measured lying down, sitting, and standing. Caregivers assist participants, and the research team frequently oversees the process. The study helps determine if activity monitoring can provide a more reliable way to measure treatment effects over a total of three weeks plus assessments.
CONDITIONS
Brief 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
- Diagnosed with possible or probable Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension
- Neurogenic orthostatic hypotension defined by a 6 30 mmHg drop in systolic blood pressure within 3 minutes of standing and impaired autonomic reflexes
- Currently treated with midodrine or atomoxetine and experiencing some symptom improvement but still symptomatic (OHSA score 1 to 5)
- Able to stay with a caregiver during study participation
- Able and willing to provide informed consent
You will not qualify if you...
- Bedridden, physically disabled, or unable to walk
- Orthostatic hypotension symptom assessment (OHSA) score 6 or systolic blood pressure drop 6 30 mmHg while 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 mellitus, amyloidosis, monoclonal gammopathies, or autoimmune neuropathies
- Clinically unstable coronary artery disease or major cardiovascular or neurological events in past 6 months
- Using anticoagulant medications
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to determine eligibility and obtain consent
Duration - 3 weeks total (7 days treatment, 7 days placebo, 7 days washout in between)
Participants will undergo two separate 7-day periods wearing an activity monitor to measure upright time and other walking activities while taking either a placebo or their regular treatment medication. The order of treatment and placebo weeks is randomized and blinded. Participants will log daily activities and complete questionnaires and blood pressure measurements at the end of each week.
3 visits: one baseline visit, one visit after the first week, and one visit after the second week for assessments and guidance
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
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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