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NCT03541018 Clinical Trial

Different Treatments With the TRV Reposition Chair

Benign Paroxysmal Positional Vertigo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03541018
Other study ID # VEST01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date January 1, 2022

Study information
Verified date July 2022
Source Aalborg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Type of repositional maneuvre
Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV

Locations
Country Name City State
Denmark Department of Otolaryngology, Head & Neck Surgery and Audiology Aalborg North Denmark Region

Sponsors (1)
Lead Sponsor Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation by VNG Measurements Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures. 2 years
Primary Subjective vertigo A systematic registration of experienced vertigo during each diagnostic procedure will take place. 2 years
Secondary Dizziness Handicap Inventory (DHI) questionnaire Pre-treatment fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo. 2 years
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