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Different Treatments With the TRV Reposition Chair

Sponsor
Aalborg University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03541018
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
48
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Type of repositional maneuvre
 N/A

Detailed Description

Patients diagnosed with BPPV with subtypes of either posterior canalolithiasis or lateral cupulolithiasis will we considered for enrollment. Each subgroup of patients will undergo randomization for a specific treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Which Repositional Maneuver is the Most Successful When Treating Lateral and Posterior Benign Paroxysmal Positional Vertigo With the TRV Repositional Chair?
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Posterior canalolithiasis

Type of repositional maneuvre

Procedure: Type of repositional maneuvre
Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV
Experimental: Lateral cupulolithiasis

Type of repositional maneuvre

Procedure: Type of repositional maneuvre
Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV

Outcome Measures

Primary Outcome Measures

  1. Evaluation by VNG Measurements [2 years]

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

  2. Subjective vertigo [2 years]

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

Secondary Outcome Measures

  1. Dizziness Handicap Inventory (DHI) questionnaire [2 years]

    Pre-treatment fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age above 18 years of age

  • Medical history compatible with BPPV

  • Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.

Exclusion Criteria:

  • Former treatment with a repositional Chair

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Otolaryngology, Head & Neck Surgery and Audiology Aalborg North Denmark Region Denmark 9000

Sponsors and Collaborators

  • Aalborg University Hospital

Investigators

  • Principal Investigator: Dan D Hougaard, MD, Aalborg University Hospital, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dan Dupont Hougaard, MD, Assistant Professor, Aalborg University Hospital
ClinicalTrials.gov Identifier:
NCT03541018
Other Study ID Numbers:
  • VEST01
First Posted:
May 30, 2018
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dan Dupont Hougaard, MD, Assistant Professor, Aalborg University Hospital
TRV Reposition Chair
Epley Maneuvre
Additional relevant MeSH terms:
Vertigo
Benign Paroxysmal Positional Vertigo
Dizziness

Study Results

No Results Posted as of Jul 29, 2022