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Accelerometer Monitoring for Neurogenic Orthostatic Hypotension

N/A
Recruiting
Led By Italo Biaggioni, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are able to stay with their caregiver during study participation
Possible or probable Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days of treatment or placebo period
Awards & highlights

Study Summary

This trial is looking for a more objective way to assess the efficacy of treatments for neurogenic orthostatic hypotension, by using an activity monitor to track how long patients spend in the upright position during a week on placebo and a week on their regular medication.

Who is the study for?
This trial is for people aged 40-80 with conditions like Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease who have low blood pressure upon standing. They must be on midodrine or atomoxetine treatment and not bedridden, pregnant, or have had recent major cardiovascular events.Check my eligibility
What is being tested?
The study tests if an accelerometer can better measure the effectiveness of treatments for neurogenic orthostatic hypotension compared to questionnaires. Participants will take either their regular medication or a placebo pill while wearing the activity monitor.See study design
What are the potential side effects?
Midodrine may cause scalp tingling, chills, urinary urgency; Atomoxetine might lead to dry mouth, insomnia, increased heart rate. Placebos typically do not cause side effects but can trigger a psychological response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can stay with my caregiver during the study.
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I may have a condition like MSA, PAF, or Parkinson's with low blood pressure when standing.
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I have been diagnosed with a condition that causes low blood pressure when I stand.
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I am between 40 and 80 years old.
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I am taking medication for low blood pressure upon standing and still have symptoms.
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I experience significant drops in blood pressure upon standing due to a nerve condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days of treatment or placebo period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days of treatment or placebo period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Orthostatic symptoms
Total standing time measured by an accelerometer
Secondary outcome measures
Total number of steps measured by an accelerometer
Total walking time measured by an accelerometer

Side effects data

From 2022 Phase 2 trial • 92 Patients • NCT02713126
59%
Dizziness
54%
Miscellaneous - Blister/Bloody nose/Cataract/Dry Mouth/Acne
41%
Muscle and Joint Pain
35%
Cold/SoreThroat/Flu
32%
Upset stomach/diarrhea
30%
Chest pain
27%
Cough
27%
Shortness of Breath
27%
Headache
19%
General Minor Injury - Fall/Bruise/Cut
14%
Nausea
8%
Fatigue
5%
Pneumonia
5%
Rash
5%
Bad Taste in Mouth
5%
Weight Gain
5%
Arrhythmia
5%
Mood Changes - Depressed/Edgy/Forgetful
5%
Edema
5%
Severe Chest/Neck/Jaw Pain
3%
Shortness of Breath - Worsening Heart Failure
3%
Syncope/Stent placement
3%
Revascularization
3%
Numbness/Pins and Needles
3%
Black Stool
3%
Worsening Renal Function
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sodium Nitrite
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: placeboExperimental Treatment2 Interventions
Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.
Group II: Standard treatmentActive Control2 Interventions
Either midodrine or atomoxetine at their regular dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Accelerometer
2020
Completed Phase 2
~460
placebo pill
2005
Completed Phase 4
~350

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
671,017 Total Patients Enrolled
Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
28 Previous Clinical Trials
1,425 Total Patients Enrolled

Media Library

Midodrine or atomoxetine pill (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04782830 — N/A
Neurogenic Orthostatic Hypotension Research Study Groups: placebo, Standard treatment
Neurogenic Orthostatic Hypotension Clinical Trial 2023: Midodrine or atomoxetine pill Highlights & Side Effects. Trial Name: NCT04782830 — N/A
Midodrine or atomoxetine pill (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04782830 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants able to join this clinical experiment at present?

"Affirmative. The clinicaltrial.gov website displays that this scientific examination, which was first advertised on February 5th 2021, is actively seeking volunteers. A total of 29 participants need to be enrolled from one medical facility."

Answered by AI

Have any senior citizens been selected to participate in the trial?

"Eligibility for this medical research is restricted to patients between the age of 40 and 80. 16 trials are set aside specifically for those below 18 years old, while 158 trials were designated for seniors above 65."

Answered by AI

What is the aggregate count of participants in this investigation?

"Affirmative. As per the information on clinicaltrials.gov, this research endeavour is still recruiting participants; it was initially posted on February 5th 2021 and recently modified on March 10th 2022. 29 patients are required from a single site location for commencement of the trial."

Answered by AI

Does my profile meet the criteria to enter this medical trial?

"This trial is open to 29 qualified individuals who possess pure autonomic failure and are between 40-80 years of age."

Answered by AI

Who else is applying?

What site did they apply to?
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1 spots leftby Jun 2024