Vestibular Outcomes in Vestibular Schwannoma

Active, not recruiting

• Conditions: Vestibular Schwannoma

• Registration Number: NCT03346889
• Lead Sponsor: Haukeland University Hospital

Brief 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.

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 Timeline

• Study Start: 2017-04-23
• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Primary Completion: 2019-06-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dizziness Handicap Inventory (DHI)	Baseline and 1-year follow-up	25-item symptom score 0 - 100 points on dizziness handicap severity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Hordaland, Norway