Vestibular Outcomes in Vestibular Schwannoma

NCT03346889 | Active Not Recruiting

• 1 other identifier: 2017/765 C
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma

Keywords

vestibular evoked myogenic potentials; head impulse testing; quality of life

Outcome Measures

Primary Outcomes (1)

• Dizziness Handicap Inventory (DHI)

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

  Baseline and 1-year follow-up

Secondary Outcomes (5)

• Vertigo Symptom Scale Short Form

  Baseline and 1-year follow-up

• Haukeland Dizziness Questionnaire (HDQ-10)

  Baseline and 1-year follow-up

• Vertigo Visual Analog Scale

  Baseline and 1-year follow-up

• Hospital Anxiety and Depression Scale (HADS)

  Baseline and 1-year follow-up

• RAND-12

  Baseline and 1-year follow-up

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Hordaland, 5009, Norway

Location

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

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

Study Officials

• Frederik K Goplen, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: April 23, 2017
• Primary Completion: June 25, 2019
• Study Completion: December 31, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)