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Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms

NCT04782830 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-06-26

No results posted yet for this study

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

Interventions

DEVICE

Accelerometer

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.

DRUG

placebo pill

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

DRUG

Midodrine or atomoxetine pill

Either midodrine or atomoxetine at their regular dose.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Italo Biaggioni, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2027-06-01
Completion
2027-10-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04782830 on ClinicalTrials.gov