NCT03541018

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month 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

3.9 years

First QC Date

May 4, 2018

Last Update Submit

July 28, 2022

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

TRV Reposition ChairEpley Maneuvre

Outcome Measures

Primary Outcomes (2)

  • Evaluation by VNG Measurements

    Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures.

    2 years

  • Subjective vertigo

    A systematic registration of experienced vertigo during each diagnostic procedure will take place.

    2 years

Secondary Outcomes (1)

  • Dizziness Handicap Inventory (DHI) questionnaire

    2 years

Study Arms (2)

Posterior canalolithiasis

EXPERIMENTAL

Type of repositional maneuvre

Procedure: Type of repositional maneuvre

Lateral cupulolithiasis

EXPERIMENTAL

Type of repositional maneuvre

Procedure: Type of repositional maneuvre

Interventions

Type of repositional maneuvrePROCEDURE

Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV

Lateral cupulolithiasisPosterior canalolithiasis

Eligibility Criteria

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

You may qualify if:

  • Age above 18 years of age
  • Medical history compatible with BPPV
  • Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.

You may not qualify if:

  • Former treatment with a repositional Chair
  • Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair

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 Vertigo

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dan D Hougaard, MD

    Aalborg University Hospital, Denmark

    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, Assistant Professor

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 30, 2018

Study Start

January 1, 2018

Primary Completion

December 1, 2021

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)