Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms

NCT04782830 | Recruiting

• 1 other identifier: 201219
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

orthostatic hypotension; autonomic failure; accelerometer; orthostatic symptoms

Outcome Measures

Primary Outcomes (2)

• Total standing time measured by an accelerometer

  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.

  7 days of the treatment or placebo period

• Orthostatic symptoms

  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.

  7 days of treatment or placebo period

Secondary Outcomes (2)

• Total number of steps measured by an accelerometer

  7 days of treatment or placebo period

• Total walking time measured by an accelerometer

  7 days of treatment or placebo period

Study Arms (2)

placebo

EXPERIMENTAL

Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.

Device: Accelerometer; Drug: placebo pill

Standard treatment

ACTIVE COMPARATOR

Either midodrine or atomoxetine at their regular dose.

Device: Accelerometer; Drug: Midodrine or atomoxetine pill

Interventions

Accelerometer DEVICE

A uniaxial accelerometer-based activity monitor (ActivpalTM) will be worn by participants on one of the thighs during the 7 days of the placebo and treatment periods.

Also known as: ActivpalTM

Standard treatment; placebo

placebo pill DRUG

Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.

Also known as: sugar pill

placebo

Midodrine or atomoxetine pill DRUG

Either midodrine or atomoxetine at their regular dose.

Standard treatment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Hypotension; Pure Autonomic Failure; Multiple System Atrophy; Parkinsonian Disorders; Hypotension, Orthostatic

Interventions

Sugars; Midodrine; Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Orthostatic Intolerance

Intervention Hierarchy (Ancestors)

Carbohydrates; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Propylamines

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bonnie K Black, RN

CONTACT

615-343-6862; autonomics@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessor will be blinded to the study medications
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Model Details: placebo-controlled, double-blind, randomized crossover

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: February 5, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)