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

BPPV Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871413
• Other study ID #: TRV002
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: July 2020
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• BPPV
• Dizziness
• Vertigo

Intervention

Device:
• TRV-chair
Repositioning maneuvers in TRV-chair

Procedure:
• Manual repositioning maneuver
Treatment with manual repositioning maneuver

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	Number of treatments	Number of treatment necessary to achieve resolution of vertigo and nystagmus	2 years
Primary	Treatment success after first treatment	Number of subjects achieving resolution of vertigo and nystagmus after one treatment	2 years
Secondary	Dizziness Handicap Inventory (DHI) questionnaire	Comparison of pre-treatment score and post-treatment score	2 years
Secondary	Adverse events	Registration of adverse events	2 years