Vestibular Outcomes in Vestibular Schwannoma

Vestibular Schwannoma Clinical Trial

— VOVS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03346889
• Other study ID #: 2017/765 C
• Status: Active, not recruiting
• Start date: April 23, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: December 31, 2023
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Hordaland

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dizziness Handicap Inventory (DHI)	25-item symptom score 0 - 100 points on dizziness handicap severity	Baseline and 1-year follow-up
Secondary	Vertigo Symptom Scale Short Form	15-item symptom score 0 - 60 points on vertigo symptom quality	Baseline and 1-year follow-up
Secondary	Haukeland Dizziness Questionnaire (HDQ-10)	10-item symptom score 0 - 30 points on vertigo symptom severity	Baseline and 1-year follow-up
Secondary	Vertigo Visual Analog Scale	100 mm visual analog scale on vertigo symptom severity	Baseline and 1-year follow-up
Secondary	Hospital Anxiety and Depression Scale (HADS)	14-item anxiety and depression score 0 - 42 points	Baseline and 1-year follow-up
Secondary	RAND-12	12-item health-related quality of life score	Baseline and 1-year follow-up