RecruitingNot ApplicableNCT04782830

Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms


Sponsor

Vanderbilt University Medical Center

Enrollment

29 participants

Start Date

Feb 5, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Accelerometer, a drug called Midodrine or atomoxetine pill, and others for people with autonomic failure, multiple system atrophy, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 40 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAccelerometer

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.

DRUGplacebo pill

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

DRUGMidodrine or atomoxetine pill

Either midodrine or atomoxetine at their regular dose.


Locations(1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT04782830


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