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NCT04782830 · ClinicalTrials.gov registry record · NA
Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
A NA study of Multiple System Atrophy and Autonomic Failure, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT04782830: Recruiting NA study of Multiple System Atrophy and Autonomic Failure, sponsored by Vanderbilt University Medical Center.
NCT04782830 is a NA study of Multiple System Atrophy and Autonomic Failure that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 29 participants, below the 267-participant average among 30 other Multiple System Atrophy trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04782830, a NA study of Multiple System Atrophy and Autonomic Failure, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Accelerometer
- DRUG placebo pill
- DRUG Midodrine or atomoxetine pill
Study Locations (1)
Tennessee
- Autonomic Dysfunction Center/ Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2021-02-05 |
| Est. Completion | 2027-10-01 |
| Phase | NA |
What NCT04782830 shows while recruiting
NCT04782830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 267-participant average among 30 other Multiple System Atrophy trials with a reported enrollment target (89% lower).
The record links to 5 conditions, with Multiple System Atrophy appearing as the primary indexed condition, and to 3 interventions - of which Accelerometer is the first listed.
NCT04782830 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04782830 about?
NCT04782830 is a clinical study titled "Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms". 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 a...
What is the current status of trial NCT04782830?
This trial is currently recruiting. It is a NA study. The enrollment target is 29 participants. The study started on 2021-02-05. Estimated completion is 2027-10-01.
What conditions does trial NCT04782830 study?
This clinical trial studies the following conditions: Multiple System Atrophy, Autonomic Failure, Pure Autonomic Failure, Orthostatic; Hypotension, Neurogenic, Orthostatic; Hypotension, Parkinsonism.
What interventions are being tested in trial NCT04782830?
The interventions under investigation include: Accelerometer (DEVICE), placebo pill (DRUG), Midodrine or atomoxetine pill (DRUG).
Who is sponsoring clinical trial NCT04782830?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04782830 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04782830's enrollment target sits among peer trials
29 25th of 30 higher than 5 of 30 other Multiple System Atrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple System Atrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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