Vestibular SchwannomaVOVSNCT03346889
Vestibular Outcomes in Vestibular Schwannoma
An observational study of Vestibular Schwannoma, run by Haukeland University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vestibular Schwannoma
- How many people
- 155 participants
- Where
- 1 siteNorway
- Study dates
- 23 Apr 2017to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients living i Norway referred to Haukeland University Hospital due to newly diagnosed, untreated vestibular schwannoma
Who cannot join
- Inability to undergo test protocol due to physical or language barriers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vertigo Symptoms, Balance and Vestibular Function in Patients With 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.
Read the 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.
- Conditions
- Vestibular Schwannoma
- Keywords
- vestibular evoked myogenic potentials, head impulse testing, quality of life
- Medical subject headings
- Neuroma, Acoustic
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory (DHI)
25-item symptom score 0 - 100 points on dizziness handicap severity
Measured: Baseline and 1-year follow-up
Secondary outcomes (5)
Vertigo Symptom Scale Short Form
15-item symptom score 0 - 60 points on vertigo symptom quality
Measured: Baseline and 1-year follow-up
Haukeland Dizziness Questionnaire (HDQ-10)
10-item symptom score 0 - 30 points on vertigo symptom severity
Measured: Baseline and 1-year follow-up
Vertigo Visual Analog Scale
100 mm visual analog scale on vertigo symptom severity
Measured: Baseline and 1-year follow-up
Hospital Anxiety and Depression Scale (HADS)
14-item anxiety and depression score 0 - 42 points
Measured: Baseline and 1-year follow-up
RAND-12
12-item health-related quality of life score
Measured: Baseline and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start23 Apr 2017
- Primary completion25 Jun 2019
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederik K Goplen, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346889
- Sponsor's protocol ID
- 2017/765 C
- Acronym
- VOVS
- Status last verified
- Oct 2024
- First submitted
- 15 Nov 2017
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertigo Symptoms, Balance and Vestibular Function in Patients With Vestibular Schwannoma
- ClinicalTrials.gov ID
- NCT03346889
- Acronym / sponsor ID
- VOVS / 2017/765 C
- Conditions
- Vestibular Schwannoma
- Keywords
- vestibular evoked myogenic potentials, head impulse testing, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 23 Apr 2017 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients living i Norway referred to Haukeland University Hospital due to newly diagnosed, untreated vestibular schwannoma
Key exclusion criteria (1 listed)
- Inability to undergo test protocol due to physical or language barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dizziness Handicap Inventory (DHI)
Time frame: Baseline and 1-year follow-up
25-item symptom score 0 - 100 points on dizziness handicap severity
5 secondary outcomes
Vertigo Symptom Scale Short Form
Time frame: Baseline and 1-year follow-up
Haukeland Dizziness Questionnaire (HDQ-10)
Time frame: Baseline and 1-year follow-up
Vertigo Visual Analog Scale
Time frame: Baseline and 1-year follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and 1-year follow-up
RAND-12
Time frame: Baseline and 1-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik K Goplen, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Schwannoma, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (DHI) (time frame: Baseline and 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.