NCT04147156

Brief Summary

A study to establish the efficacy of a new type of mechanical rotational chair in treating BPPV. In addition, comparison of three types of treatment maneuvers using the mechanical rotational chair.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 27, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

October 30, 2019

Last Update Submit

July 28, 2022

Conditions

BPPV

Keywords

Benign Paroxysmal Positional VertigoVertigoDizzinessVestibular diseasesEpley ManeuverSemont ManeuverRepositioning chair

Outcome Measures

Primary Outcomes (2)

  • Number of treatments

    Number of treatments 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 (3)

  • Dizziness Handicap Inventory (DHI) questionnaire

    2 years

  • Adverse events

    2 years

  • Value of liberatory nystagmus

    2 years

Study Arms (3)

Epley's Maneuver

ACTIVE COMPARATOR

Treatment of posterior canal BPPV with Epley's maneuver in the ROTUNDUM-chair.

Procedure: Epley's Maneuver

Semont Maneuver

EXPERIMENTAL

Treatment of posterior canal BPPV with the Semont maneuver in the ROTUNDUM-chair.

Procedure: Semont Maneuver

360 degree vertical rotation

ACTIVE COMPARATOR

Treatment of posterior canal BPPV with a 360 degree vertical rotation in the ROTUNDUM-chair.

Procedure: 360 degree vertical rotation

Interventions

Epley's ManeuverPROCEDURE

Treatment with Epley's Maneuver in the ROTUNDUM-chair

Epley's Maneuver
Semont ManeuverPROCEDURE

Treatment with the Semont Maneuver in the ROTUNDUM-chair

Semont Maneuver
360 degree vertical rotationPROCEDURE

Treatment with 360 degree vertical rotation in the ROTUNDUM-chair

360 degree vertical rotation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Treatment in a mechanical rotational chair within the last 6 months
  • Lack of treatment cooperation
  • Known cerebral aneurism or cerebral hemorrhage
  • Treated for BPPV within the past month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology, Head & Neck Surgery and Audiology

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoVertigoDizzinessVestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSensation 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

October 30, 2019

First Posted

October 31, 2019

Study Start

February 27, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)