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

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ClinicalTrials.gov Identifier: NCT03871413
Recruitment Status : Enrolling by invitation
First Posted : March 12, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dan Dupont Hougaard, Aalborg University Hospital

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

Condition or disease Intervention/treatment Phase
BPPV Device: TRV-chair Procedure: Manual repositioning maneuver Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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?
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of treatments [ Time Frame: 2 years ]
    Number of treatment necessary to achieve resolution of vertigo and nystagmus

  2. Treatment success after first treatment [ Time Frame: 2 years ]
    Number of subjects achieving resolution of vertigo and nystagmus after one treatment


Secondary Outcome Measures :
  1. Dizziness Handicap Inventory (DHI) questionnaire [ Time Frame: 2 years ]
    Comparison of pre-treatment score and post-treatment score

  2. Adverse events [ Time Frame: 2 years ]
    Registration of adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871413


Locations
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Denmark
Department of Otolaryngology, Head & Neck Surgery and Audiology
Aalborg, North Denmark Region, Denmark, 9000
Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Principal Investigator: Dan D Hougaard, MD Aalborg University Hospital

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Responsible Party: Dan Dupont Hougaard, MD, Associate Professor, Principal Investigator, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03871413     History of Changes
Other Study ID Numbers: TRV002
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dan Dupont Hougaard, Aalborg University Hospital:
Benign Paroxysmal Positional Vertigo
Vertigo
Dizziness
Vestibular Diseases
Epley Maneuver
TRV-chair
Repositioning chair
Additional relevant MeSH terms:
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Vertigo
Benign Paroxysmal Positional Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders