Vestibular Outcomes in Vestibular Schwannoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03346889
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Haukeland University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Frederik K Goplen, PhD
Principal Investigator Affiliation Haukeland University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Vestibular Schwannoma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Haukeland University Hospital, Bergen, Hordaland, Norway

Status

Recruiting

Address

Haukeland University Hospital

Bergen, Hordaland, 5009

Site Contact

Frederik Goplen, PhD

frederik.goplen@helse-bergen.no

+4755975000

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