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NCT Number: NCT03346889

Vestibular Outcomes in 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Vestibular Schwannoma Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neuroectodermal Tumors Neuroendocrine Tumors Neuroma Neuroma, Acoustic Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Peripheral Nervous System Neoplasms Retrocochlear Diseases Vestibulocochlear Nerve Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, Hordaland, 5009, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dizziness Handicap Inventory (DHI)

    Time frame: Baseline and 1-year follow-up

    25-item symptom score 0 - 100 points on dizziness handicap severity

Secondary outcomes

  1. Vertigo Symptom Scale Short Form

    Time frame: Baseline and 1-year follow-up

    15-item symptom score 0 - 60 points on vertigo symptom quality

  2. Haukeland Dizziness Questionnaire (HDQ-10)

    Time frame: Baseline and 1-year follow-up

    10-item symptom score 0 - 30 points on vertigo symptom severity

  3. Vertigo Visual Analog Scale

    Time frame: Baseline and 1-year follow-up

    100 mm visual analog scale on vertigo symptom severity

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline and 1-year follow-up

    14-item anxiety and depression score 0 - 42 points

  5. RAND-12

    Time frame: Baseline and 1-year follow-up

    12-item health-related quality of life score

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

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

Acronym: VOVS

Important dates

Study start
2017
Primary completion
2019
Study completion
2025
First posted
Nov 20, 2017
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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