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RECRUITING
NCT04782830
NA

Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2021-02-05

Completion Date

2027-10-01

Last Updated

2025-06-26

Healthy Volunteers

No

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.

Locations (1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, United States