drugset / Trial / NCT04782830

Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms

NCT04782830

Recruiting 29 enrolled Vanderbilt University Medical Center
RandomizedCrossoverDouble-blindOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atomoxetine Other / unclassified
Comparator Midodrine Small molecule