Using an accelerometer to measure symptoms of neurogenic orthostatic hypotension

Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms

This study is testing if using a device to track how long people with neurogenic orthostatic hypotension can stay upright helps show if their medication works better than a placebo.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT04782830 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-80 with neurogenic orthostatic hypotension due to conditions like Multiple Systems Atrophy or Parkinson's disease, who are currently on treatment but still experience symptoms.

Not a fit: Patients who are bedridden, physically disabled, or unable to walk will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate assessments of treatment efficacy for patients suffering from neurogenic orthostatic hypotension.

How similar studies have performed: While the use of accelerometers in this context is relatively novel, similar studies have shown promise in objectively measuring symptoms in other conditions.

Eligibility criteria

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 this trial is running

Nashville, Tennessee

• 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

Conditions: Orthostatic, Hypotension, Neurogenic, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Hypotension, Parkinsonism, orthostatic hypotension, autonomic failure