Skip to main content
OpenTrials
Completed

NCT Number: NCT03871413

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

BPPV Benign Paroxysmal Positional Vertigo Dizziness Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otolaryngology, Head & Neck Surgery and Audiology

Aalborg, North Denmark, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRV-chair

Device

Repositioning maneuvers in TRV-chair

Manual repositioning maneuver

Procedure

Treatment with manual repositioning maneuver

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study 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?

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2019
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.