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

NCT03871413 | Completed DMC

• 1 other identifier: TRV002
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

BPPV

Keywords

Benign Paroxysmal Positional Vertigo; Vertigo; Dizziness; Vestibular Diseases; Epley Maneuver; TRV-chair; Repositioning chair

Outcome Measures

Primary Outcomes (2)

• Number of treatments

  Number of treatment necessary to achieve resolution of vertigo and nystagmus

  2 years

• Treatment success after first treatment

  Number of subjects achieving resolution of vertigo and nystagmus after one treatment

  2 years

Secondary Outcomes (2)

• Dizziness Handicap Inventory (DHI) questionnaire

  2 years

• Adverse events

  2 years

Study Arms (2)

Manual repositioning maneuver

ACTIVE COMPARATOR

Diagnostics and treatment of BPPV with manual repositioning maneuvers. In case of posterior canal involvement, Epley's maneuver will be used. In case of horizontal canal involvement, the log roll maneuver will be used.

Procedure: Manual repositioning maneuver

Treatment in mechanical rotational chair (TRV-chair)

EXPERIMENTAL

Diagnostics and treatment of BPPV with the use of a TRV chair. In case of posterior canal involvement, Epley's maneuver will be used with the addition of 10 kinetic impulses in each position. In case of horizontal canal involvement, the log roll maneuver will be used with the addition of 10 kinetic impulses in each position.

Device: TRV-chair

Interventions

TRV-chair DEVICE

Repositioning maneuvers in TRV-chair

Treatment in mechanical rotational chair (TRV-chair)

Manual repositioning maneuver PROCEDURE

Treatment with manual repositioning maneuver

Manual repositioning maneuver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Characteristic (for BPPV) positional nystagmus
• Positive Dix-Hallpike
• Positive supine roll test
• Medical history compatible with BPPV

You may not qualify if:

• Treatment in TRV-chair within the last 6 months
• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Department of Otolaryngology, Head & Neck Surgery and Audiology

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vertigo; Dizziness; Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Study Officials

• Dan D Hougaard, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)