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Active, not recruitingNCT03346889VOVSUpdated Oct 30, 2024

Vestibular Outcomes in Vestibular Schwannoma

An observational study in Vestibular Schwannoma, sponsored by Haukeland University Hospital. Active, not recruiting at 1 site in Norway. Per ClinicalTrials.gov, last updated 2024-10-30.

Sponsored by Haukeland University Hospital · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
155
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Vestibular Schwannoma

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Keywords

  • vestibular evoked myogenic potentials
  • head impulse testing
  • quality of life
03

In context

Neuroma, Acoustic

100 studies on the registry are indexed under Neuroma, Acoustic; 28 are open to participants now.

This study's enrollment of 155 is above the median of 61 across 26 observational studies indexed under Neuroma, Acoustic.

Browse Neuroma, Acoustic studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inability to undergo test protocol due to physical or language barriers
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
155 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Dizziness Handicap Inventory (DHI)

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

    Time frame: Baseline and 1-year follow-up

Secondary outcomes

  1. Vertigo Symptom Scale Short Form

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

    Time frame: Baseline and 1-year follow-up

  2. Haukeland Dizziness Questionnaire (HDQ-10)

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

    Time frame: Baseline and 1-year follow-up

  3. Vertigo Visual Analog Scale

    100 mm visual analog scale on vertigo symptom severity

    Time frame: Baseline and 1-year follow-up

  4. Hospital Anxiety and Depression Scale (HADS)

    14-item anxiety and depression score 0 - 42 points

    Time frame: Baseline and 1-year follow-up

  5. RAND-12

    12-item health-related quality of life score

    Time frame: Baseline and 1-year follow-up

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2017 to primary completion in Jun 2019, 26 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2017
First posted
Nov 20, 2017
StartActual
Apr 23, 2017
Primary completionActual
Jun 25, 2019
CompletionEst.
Dec 31, 2025
Last update
Oct 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03346889
Responsible party
Sponsor
First posted
Nov 20, 2017
Start date
Apr 23, 2017
Primary completion
Jun 25, 2019
Completion
Dec 31, 2025 (estimated)
Last update
Oct 30, 2024

Study contacts

Frederik K Goplen, PhD
principal investigator · Haukeland University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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