Vestibular Outcomes in Vestibular Schwannoma (VOVS)

October 28, 2024 updated by: Haukeland University Hospital

Vertigo Symptoms, Balance and Vestibular Function in Patients With Vestibular Schwannoma

Previous studies have shown that vertigo is the symptoms that mostly affect quality of life in patients with vestibular schwannoma. There is still limited knowledge as to why some patients with this disorder develop vertigo, while others with the same diagnosis do not. The purpose of this study is to measure symptom-related quality of life and to relate this to objective disease characteristics at baseline.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This is a longitudinal observational study with data collected at baseline and after treatment.

Variables collected at baseline include age, sex, tumor size, location, type (cystic/solid), tumor side, symptom variables including Dizziness Handicap Inventory, Vertigo Symptom Scale Short Form, Haukeland Dizziness Questionnaire, Visual analog scale, Hospital Anxiety and Depression Scale, RAND-12, dynamic posturography, video-based head impulse test, bithermal caloric tests, ocular and cervical vestibular evoked myogenic potentials.

Follow-up data after 1 year are the same patient-reported outcomes as at baseline.

Study Type

Observational

Enrollment (Actual)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Hordaland
      • Bergen, Hordaland, Norway, 5009
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients in Norway with newly diagnosed vestibular schwannoma (VS) are referred to Haukeland University Hospital for evaluation. The size of the study population therefore depends on the incidence of VS in Norway and the inclusion period. The incidence of VS in Norway is approximately 150 per year in a population of 5.2 million.

Description

Inclusion Criteria:

  • Patients living i Norway referred to Haukeland University Hospital due to newly diagnosed, untreated vestibular schwannoma

Exclusion Criteria:

  • Inability to undergo test protocol due to physical or language barriers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Inventory (DHI)
Time Frame: Baseline and 1-year follow-up
25-item symptom score 0 - 100 points on dizziness handicap severity
Baseline and 1-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertigo Symptom Scale Short Form
Time Frame: Baseline and 1-year follow-up
15-item symptom score 0 - 60 points on vertigo symptom quality
Baseline and 1-year follow-up
Haukeland Dizziness Questionnaire (HDQ-10)
Time Frame: Baseline and 1-year follow-up
10-item symptom score 0 - 30 points on vertigo symptom severity
Baseline and 1-year follow-up
Vertigo Visual Analog Scale
Time Frame: Baseline and 1-year follow-up
100 mm visual analog scale on vertigo symptom severity
Baseline and 1-year follow-up
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline and 1-year follow-up
14-item anxiety and depression score 0 - 42 points
Baseline and 1-year follow-up
RAND-12
Time Frame: Baseline and 1-year follow-up
12-item health-related quality of life score
Baseline and 1-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Frederik K Goplen, PhD, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2017

Primary Completion (Actual)

June 25, 2019

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/765 C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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