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Accelerometer Use for Neurogenic Orthostatic Hypotension Symptoms

This study is looking for a better way to measure how well treatments work for neurogenic orthostatic hypotension (a condition where your blood pressure drops significantly when you stand up). Researchers will use a special activity monitor, called an accelerometer, worn on your thigh. You would wear this monitor for one week while taking a placebo (a pill with no active ingredients) and for another week while taking your regular medication for orthostatic hypotension, either midodrine or atomoxetine. The study will compare the total time you spend standing and walking during these two periods. This will help determine if using an accelerometer is a more accurate way to assess treatment effectiveness than just asking about your symptoms. You may be able to join if you are between 40 and 80 years old and have certain conditions like Multiple System Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 29 participants. It compares the effects of a placebo against regular medication (midodrine or atomoxetine) using an accelerometer.
What's involved
Participants will wear an accelerometer on their thigh for 7 days during a placebo period and for another 7 days during a treatment period. They will also take a placebo pill and their regular medication for 7 days each.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, total standing time and orthostatic symptoms, are measured at 7 days of the treatment or placebo period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04782830

Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms

Recruiting
NAAges 40–80Interventional
Vanderbilt University Medical Center
~29 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Accelerometerplacebo pillMidodrine or atomoxetine pill

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total standing time measured by an accelerometer
Measured over 7 days of the treatment or placebo period
+1 more outcome measured

Conditions

Orthostatic; Hypotension, Neurogenic
Autonomic Failure
Pure Autonomic Failure
Multiple System Atrophy
Orthostatic; Hypotension, Parkinsonism

Explore related trials

Multiple System AtrophyParkinson DiseasePure autonomic failure

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Italo Biaggioni, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Bonnie K Black, RN
[email protected]
615-343-6862
Email the study team

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Eligibility criteria

Inclusion

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 orthostatic symptoms, but still remain symptomatic (Orthostatic hypotension symptom assessment \[OHSA\] score of 1 to 5 while on medication).
Patients who are able to stay with their caregiver during study participation.
Able and willing to provide informed consent.

Exclusion

Bedridden, physically disabled, or unable to walk.
Patients with Orthostatic hypotension symptom assessment (OHSA) score ≥ 6, or orthostatic systolic blood pressure drop ≥ 30 mmHg on their regular treatment.
Patients taking more than one medication for the treatment of neurogenic orthostatic hypotension (concomitant use of pyridostigmine or fludrocortisone are accepted).
Pregnancy
Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
Clinically unstable coronary artery disease (recurrent angina despite medical therapy), or major cardiovascular or neurological event in the past 6 months (myocardial infarction, stroke).
Concomitant use of anticoagulants.

What this trial measures

  • Total standing time measured by an accelerometer7 days of the treatment or placebo period

    The percentage of total standing time during the treatment or placebo period will be measured by an accelerometer (Activpal) placed on one of the patient's thighs. The accelerometer quantifies the length of time spent in the upright and seated or supine positions.

  • Orthostatic symptoms7 days of treatment or placebo period

    Orthostatic symptoms measured by the Orthostatic Hypotension Questionnaire (OHQ). The questionnaire is divided into two parts: Part I, Symptom Assessment (OHSA), consisted of six questions, each rating the intensity of one characteristic symptom of OH: 1) Dizziness, lightheadedness, feeling faint, or feeling like you might blackout; 2) Blurring, seeing spots or tunnel vision; 3) Generalized weakness; 4) Fatigue; 5) Trouble concentrating; 6) Head/neck discomfort; and Part II, Daily Activity Scale (OHDAS), consisted of four questions that assessed the impact of neurogenic OH symptoms on daily activities. The recall period is ''over the past week''. The items are scored on an 11-point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference, and the option of selecting ''cannot be done for other reasons''. The composite OHQ score is calculated by averaging the OHSAS and the OHDAS.