A Phase 3 interventional study of Canalith repositioning maneuver (CRM) in Benign Paroxysmal Positional Vertigo, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by McMaster University · Phase 3, Interventional, and Treatment
The purpose of this study is to see whether family doctors can treat benign paroxysmal positional vertigo (BPPV), or dizziness, using a procedure in the office. The study is looking at whether the treatment procedure cures the dizziness in more patients compared to patients that receive a "sham" or placebo procedure.
Many patients consult their family physicians because of dizziness. This is a disabling condition with serious consequences, especially in older people, as it may lead to falls and consequent fractures. One of the most common causes of dizziness is the so-called Benign Paroxysmal Positional Vertigo (BPPV). Patients with BPPV typically have severe vertigo provoked by a change in head position.
Benign Paroxysmal Positional Vertigo can now be accurately diagnosed, and distinguished form other dizziness producing conditions, in the physician's office and without any sophisticated diagnostics tools. Furthermore, it can be treated in the office setting by specific head positioning maneuvers (Canalith Repositioning Procedure) that are easy to learn and perform.
The Canalith Repositioning Procedure is currently almost exclusively performed in specialized settings by ear nose and throat (ENT) and Internal Medicine specialists. Its efficacy has been demonstrated in these settings. However, to-date no studies have been conducted in the primary care settings about the use and efficacy of the procedure, where the condition is first seen and assessed.
This is a randomized controlled trial to determine whether the procedure performed by family doctors cures dizziness.
248 studies on the registry are indexed under Vertigo; 39 are open to participants now.
This study's enrollment of 56 is close to the median of 57 across 186 interventional studies indexed under Vertigo.
Browse Vertigo studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Positive results of the Dix-Hallpike maneuver in both right and left head-hanging position;
Self-reported resolution (affirmative response to question: "Do you feel that the dizziness has completely resolved?") of vertigo and/or a negative result of the Dix-Hallpike maneuver
Duration of cure, relapse rates
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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