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Completed

NCT Number: NCT03541018

Different Treatments With the TRV Reposition Chair

To investigate which treatment option (reposition maneuver) with the TRV chair that is the most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV). Subtypes of BPPV will be examined after randomization to specific treatments.

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Key information

Conditions

Benign Paroxysmal Positional Vertigo Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms 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

Patients diagnosed with BPPV with subtypes of either posterior canalolithiasis or lateral cupulolithiasis will we considered for enrollment. Each subgroup of patients will undergo randomization for a specific treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age above 18 years of age
  • Medical history compatible with BPPV
  • Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.

Exclusion criteria

  • Former treatment with a repositional Chair
  • Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair

Treatment and study plan

Type of repositional maneuvre

Procedure

Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV

Primary outcomes

  1. Evaluation by VNG Measurements

    Time frame: 2 years

    Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures.

  2. Subjective vertigo

    Time frame: 2 years

    A systematic registration of experienced vertigo during each diagnostic procedure will take place.

Secondary outcomes

  1. Dizziness Handicap Inventory (DHI) questionnaire

    Time frame: 2 years

    Pre-treatment fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Which Repositional Maneuver is the Most Successful When Treating Lateral and Posterior Benign Paroxysmal Positional Vertigo With the TRV Repositional Chair?

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 30, 2018
Registry last updated
Jul 29, 2022

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.

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