A Phase 1/2 interventional study of automated abdominal binder and Sham binder in Orthostatic Hypotension, Autonomic Failure and Pure Autonomic Failure, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Vanderbilt University Medical Center · Phase 1/2, Interventional, and Treatment
Among 10 studies in Hypotension, Orthostatic by Vanderbilt University Medical Center — 3 open to participants now, 3 under way, none of them phase 3. Hypotension, Orthostatic · Vanderbilt University Medical Center.
Among the 10 studies in Hypotension, Orthostatic by Vanderbilt University Medical Center, this one is the only one that started in 2018, is the only one in phase 1/2, and was the 8th registered.
159 studies on the registry are indexed under Hypotension, Orthostatic; 35 are open to participants now.
Browse Hypotension, Orthostatic studies →3 of the 10 studies in Hypotension, Orthostatic by Vanderbilt University Medical Center are open now, in 1 country. Recruiting first, the newest first:
Vanderbilt University Medical Center · Sites in United States
Vanderbilt University Medical Center · Sites in United States
Vanderbilt University Medical Center · Sites in United States
By country, each count listing its studies:
Of the 23 Hypotension, Orthostatic studies recruiting now, 8 (35%) set no upper age limit and 8 (35%) stop at 75 or younger; 1 take children under 18; 4 take healthy volunteers.
This study: 40 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 2
First in 1996; this study’s year is marked. 1 started in 2018.
This study's enrollment of 28 is close to the median of 28 across 113 interventional studies indexed under Hypotension, Orthostatic.
Median enrollment 29 across the 9 interventional studies, 50 across the 1 observational. Of the 7 that completed or were terminated, 2 (29%) have results posted.
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Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
3 of the studies in Hypotension, Orthostatic by Vanderbilt University Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03042988Vanderbilt University Medical CenterOvernight Trials With Heat Stress in Autonomic Failure Patients With Supine Hypertension | 2026-11-30 |
| NCT05489575Vanderbilt University Medical CenterCPAP for the Treatment of Supine Hypertension | 2027-03-01 |
| NCT04782830Vanderbilt University Medical CenterUse of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms | 2027-06-01 |
Among the 10 studies in Hypotension, Orthostatic by Vanderbilt University Medical Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in patients with autonomic failure. The purpose of this study is to determine safety and effectiveness of the automated abdominal binder in improving orthostatic tolerance in these patients.
This is a randomized, double-blind, sham-controlled, parallel group study to compare the efficacy of the automated abdominal binder (inflated to 40 mm Hg) versus sham treatment (abdominal binder inflated to 5 mm Hg) in improving orthostatic tolerance in patients with primary autonomic failure disabled by orthostatic hypotension.
Potential participants will be admitted to the Vanderbilt Clinical Research Center for evaluation of inclusion and exclusion criteria. Eligible patients will be randomized to the active or sham binder group. Patients will then be asked to participate on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with active or sham binder combined with placebo pill t.i.d. The order of the study days will be randomized. On each study day, blood pressure and heart rate will be measured while sitting, lying down, standing and walking during the Morning Orthostatic Trial, and posture and walking tests.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the automated abdominal binder combined with placebo pill t.i.d The automated abdominal binder will be placed during the morning orthostatic trial on the active/sham binder study day. The binder will inflate automatically (\~40 mmHg) every time the participant stands up throughout the study day.
Device: automated abdominal binder · Drug: Placebo · Drug: Midodrine
Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the sham binder combined with placebo pill t.i.d. The sham binder will be placed during the morning orthostatic trial on the active/sham binder study day. The sham binder will inflate automatically (\~5 mmHg) every time the participant stands up throughout the study day.
Device: Sham binder · Drug: Placebo · Drug: Midodrine
The binder automatically inflates every time the participant stands up to apply a compression level of about 40 mmHg. Participants will wear the device throughout the active/sham study day.
The binder automatically inflates every time the participant stands up to apply a compression level of about 5 mmHg. Participants will wear the device throughout the active/sham study day.
Oral placebo will be given three times a day on the baseline day (placebo)
A midodrine pill 10mg will be given three times a day on the standard of care study day
Orthostatic tolerance
orthostatic tolerance is defined as the area under the curve of the upright systolic blood pressure (AUCSBP) during the Morning Orthostatic Trials
Time frame: After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
Orthostatic Hypotension Symptom Assessment (OHSA) Score
The Orthostatic Hypotension Symptom Assessment (OHSA) Score is the part I of the Orthostatic Hypotension Questionnaire (OHQ). It consists of six questions, each rating the intensity of one characteristic symptom of orthostatic hypotension: 1. Dizziness, lightheadedness, feeling faint, or feeling like you might black out; 2. Problems with vision (blurring, seeing spots, tunnel vision, etc.); 3. Generalized weakness; 4. Fatigue; 5. Trouble concentrating; and 6. Head/neck discomfort.The items are scored on an 11-point Likert scale from 0 to 10, with 0 indicating no symptoms and 10 indicating the worst possible symptoms. Composite score is the average of the item scores obtained at the post-intervention stand period during the Morning Orthostatic Trials
Time frame: After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
Upright time
Sum of standing and walking times
Time frame: After 10 minutes of standing and 15 minutes waking (as tolerated)
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Nov 2025, 92 months.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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