Different Treatments With the TRV Reposition Chair

Not Applicable

Completed

• Conditions: Benign Paroxysmal Positional Vertigo
• Interventions: Procedure: Type of repositional maneuvre

• Registration Number: NCT03541018
• Lead Sponsor: Aalborg University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-05-30
• Primary Completion: 2021-12-01
• Study Completion: 2022-01-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lateral cupulolithiasis	Type of repositional maneuvre	Type of repositional maneuvre
Posterior canalolithiasis	Type of repositional maneuvre	Type of repositional maneuvre

Primary Outcome Measures

Name	Time	Method
Evaluation by VNG Measurements	2 years	Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures.
Subjective vertigo	2 years	A systematic registration of experienced vertigo during each diagnostic procedure will take place.

Secondary Outcome Measures

Name	Time	Method
Dizziness Handicap Inventory (DHI) questionnaire	2 years	Pre-treatment fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.

Trial Locations

Locations (1)

Department of Otolaryngology, Head & Neck Surgery and Audiology; 🇩🇰 Aalborg, North Denmark Region, Denmark