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

NCT ID: NCT03871413

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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BPPV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manual repositioning maneuver

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.

Group Type ACTIVE_COMPARATOR

Manual repositioning maneuver

Intervention Type PROCEDURE

Treatment with manual repositioning maneuver

Treatment in mechanical rotational chair (TRV-chair)

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.

Group Type EXPERIMENTAL

TRV-chair

Intervention Type DEVICE

Repositioning maneuvers in TRV-chair

Interventions

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TRV-chair

Repositioning maneuvers in TRV-chair

Intervention Type DEVICE

Manual repositioning maneuver

Treatment with manual repositioning maneuver

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dan Dupont Hougaard

MD, Associate Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan D Hougaard, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

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Department of Otolaryngology, Head & Neck Surgery and Audiology

Aalborg, North Denmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TRV002

Identifier Type: -

Identifier Source: org_study_id

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