Using an accelerometer to measure symptoms of neurogenic orthostatic hypotension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to objectively assess the effectiveness of treatments for neurogenic orthostatic hypotension by using an accelerometer to monitor the time patients spend upright. Participants will undergo a week of placebo treatment followed by a week of their regular medication (midodrine or atomoxetine) while their upright time is recorded. The study will compare total upright time between the two treatment phases to evaluate if this method provides a more accurate assessment of treatment efficacy compared to traditional symptom questionnaires. The goal is to improve the understanding and management of symptoms associated with autonomic failure.

Why it matters

Who can join: the full rules

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 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 Criteria:

* 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.

Where it's running

• Autonomic Dysfunction Center/ Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Italo Biaggioni, MD — Vanderbilt University Medical Center
• Study coordinator: Bonnie K Black, RN
• Email: autonomics@vumc.org
• Phone: 615-343-6862

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.