TRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo

Can Benign Paroxysmal Positional Vertigo (BPPV) be Treated Faster and More Efficiently by Using a Mechanical Rotational Chair Compared to the Traditional Manual Repositioning Maneuvers?

Comparison of treatment efficacy of a mechanical rotational chair (TRV-chair) vs. manual repositioning maneuvers in BPPV

Study Overview

• Status: Completed
• Conditions: BPPV
• Intervention / Treatment: Procedure: Manual repositioning maneuver; Device: TRV-chair

Detailed Description

Open-label, randomized controlled trial comparing manual repositioning maneuvers with a mechanical rotational chair (TRV-chair) in diagnosing and treating BPPV. Patients with suspected BPPV will be randomized to either manual repositioning maneuvers or the TRV-chair.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • North Denmark Region
    • Aalborg, North Denmark Region, Denmark, 9000
      • Department of Otolaryngology, Head & Neck Surgery and Audiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Characteristic (for BPPV) positional nystagmus
• Positive Dix-Hallpike
• Positive supine roll test
• Medical history compatible with BPPV

Exclusion Criteria:

• Treatment in TRV-chair within the last 6 months
• Exclusion of BPPV diagnosis
• Lack of treatment cooperation
• Known cerebral aneurism or cerebral hemorrhage
• Diagnosed and treated for BPPV within the past month
• Treatment with sedating anti-histamines within the past 7 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual repositioning maneuver; Diagnostics and treatment of BPPV with manual repositioning maneuvers. In case of posterior canal involvement, Epley's maneuver will be used. In case of horizontal canal involvement, the log roll maneuver will be used.	Procedure: Manual repositioning maneuver; Treatment with manual repositioning maneuver
Experimental: Treatment in mechanical rotational chair (TRV-chair); Diagnostics and treatment of BPPV with the use of a TRV chair. In case of posterior canal involvement, Epley's maneuver will be used with the addition of 10 kinetic impulses in each position. In case of horizontal canal involvement, the log roll maneuver will be used with the addition of 10 kinetic impulses in each position.	Device: TRV-chair; Repositioning maneuvers in TRV-chair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatments	Number of treatment necessary to achieve resolution of vertigo and nystagmus	2 years
Treatment success after first treatment	Number of subjects achieving resolution of vertigo and nystagmus after one treatment	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dizziness Handicap Inventory (DHI) questionnaire	Comparison of pre-treatment score and post-treatment score	2 years
Adverse events	Registration of adverse events	2 years

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Dan D Hougaard, MD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Benign Paroxysmal Positional Vertigo; Vertigo; Dizziness; Vestibular Diseases; Epley Maneuver; TRV-chair; Repositioning chair
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: TRV002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No