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NCT03161470 · ClinicalTrials.gov registry record · NA
Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
A NA study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT03161470 is a NA study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 13 participants.
The verdict
NCT03161470, a NA study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
Benign paroxysmal positional vertigo (BPPV) is the most common inner ear cause of dizziness. It has been reported that up to 900 of every 10,000 people in the United States experience this problem with an estimated annual healthcare cost approaching $2 Billion. This problem occurs when calcium carbonate "crystals" which are present and needed in one part of the balance area of the inner ear become displaced to a different part of the balance area. This is very disruptive to the function of the inner ear and results primarily in intense vertigo. Nausea,imbalance, and falls can also occur. The accepted course of management for BPPV is the use of "repositioning maneuvers" which are completed by moving patients through specific head/body positions that literally reposition the displaced crystals out of the wrong area. These treatment methods are reported to be effective for about 80% of patients after one-to-three treatments. For the remaining 20% of patients, more treatments may be necessary and for a small percentage of patients surgical options may be the only cure. Additionally, some patients with BPPV are not able to physically move into the needed positions because of hip and neck problems, spinal problems, obesity, other mobility limitations, etc. Within the past decade, a motorized chair was developed to help reposition any patient with BPPV. There have been no reported adverse incidents with the motorized chair but the device was quite expensive so it was only available at a handful of clinical sites. At this time the motorized chair is no longer being manufactured. More recently, a mechanical chair was developed and has been in use in Europe and China. The mechanical chair has all the advantages of the motorized chair but with a lesser cost. The inventor of the mechanical chair has also developed some slight variations on treatment technique that may have the potential to improve treatment efficacy. We are privileged to have the only mechanical chair of this t
Interventions
- OTHER Sham Treatment
- OTHER Standard Repositioning
- OTHER Mechanical Chair Repositioning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2020-09-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03161470
The ClinicalTrials.gov registry entry for NCT03161470 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sham Treatment is the first listed.
NCT03161470 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03161470 about?
NCT03161470 is a clinical study titled "Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV)". Benign paroxysmal positional vertigo (BPPV) is the most common inner ear cause of dizziness. It has been reported that up to 900 of every 10,000 people in the United States experience this problem with an estimated annual healthcare cost approaching $2 Billion. This problem occurs when calcium carbo...
What is the current status of trial NCT03161470?
This trial is currently terminated. It is a NA study. The enrollment target is 13 participants. The study started on 2017-06-08. Estimated completion is 2020-09-05.
What interventions are being tested in trial NCT03161470?
The interventions under investigation include: Sham Treatment (OTHER), Standard Repositioning (OTHER), Mechanical Chair Repositioning (OTHER).
Who is sponsoring clinical trial NCT03161470?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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