Relationship Between Degree of Hypofunction and Vestibular Tests in Patients With Vestibular Hypofunction

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 12 to 85 years
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Investigation of the Relationship Between the Degree of Hypofunction and Vestibular Tests in Patients With Vestibular Hypofunction

Conditions

Videonystagmography, Vestibular Assessment

Being tested

Vestibular Hypofunction Group

Keywords

Vestibular Hypofunction, Degree of Vestibular Hypofunction, Vestibular Tests

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Vestibular Hypofunction GroupDiagnostic test

  Demographic information form, vestibular tests, balance tests will be used in the evaluation. The demographic information form includes demographic information (name, surname, gender, smoking, alcohol use, etc.) and clinical conditions (past illnesses and/or surgeries, medications used, whether there is a history of falls, if any, frequency, whether they are afraid of heights and uncomfortable in the dark, etc.). The patients will be diagnosed with videonystagmography (VNG) after the decision of the ENT physician, and their hypofunction levels will be recorded. Vestibular and balance tests will be applied to the patients in the clinical setting. At the end of the study, it will be examined whether there is a relationship between the degree of vestibular hypofunction and the vestibular tests applied in the clinic.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Demographic information and data collection form

   This form will ask questions about the patient's age, gender, occupation, whether or not they smoke or drink alcohol, accompanying illnesses, previous surgeries, medications they use, daily activity level, history of the disease, onset and type of the disease, whether or not they have fallen in the last year and if so, how many falls, fear of heights, fear of darkness and discomfort with crowds.

   Measured: through study completion, average 2 months

2. Unterberger Test

   It is a test that shows which labyrinth is affected and cannot function in peripheral vestibular diseases. The patient makes a counting movement in place 50 times with his eyes closed. If there is a deviation of 45 degrees or more to the right or left after the counting movement, this gives us information that the labyrinth on that side cannot function.

   Measured: through study completion, average 2 months

3. Dynamic Visual Acuity

   It is the situation where the visual event is realized clearly while moving. The test is started by passively moving the patient's head in the horizontal plane with a 20° amplitude and 2 Hz speed and the patient starts reading the letters on the Snellen card. The line that can be seen clearly is recorded. The dynamic visual acuity score is the difference between the number of lines on the visual graph when the head is moving passively against the stationary head. In healthy individuals, visual acuity may change by one line in young individuals and by two lines in older individuals. In uncompensated patients, the degree of visual acuity may change by three or two lines in unilateral vestibular losses.

   Measured: through study completion, average 2 months

4. Head Thrust Test

   It is a test used to evaluate the function of the vestibulo-ocular reflex (VOR). The head thrust test can be applied in all planes of the semicircular canals. The patient sits on a chair. The physiotherapist or the practitioner stands in front of the patient. The patient is asked to focus on his nose and the patient's head is held and the head is rotated in a horizontal plane with low amplitude and high acceleration. The patient's ability to keep his eyes fixed on the practitioner's nose indicates that there is no problem in the VOR, while corrective saccadic movement indicates that the test is positive.

   Measured: through study completion, average 2 months

5. Timed Balance Tests

   Tandem, semitandem, romberg, tek ayak üzerinde durma testleri uygulanacaktır. Bu testler gözler açık ve kapalı olacak şekilde uygulanacaktır. Tek ayak üzerinde durma testleri yumuşak zemin ve sert zeminde olmak üzere iki farklı zeminde yapılacaktır. Testler (sn) olarak ölçülecektir.

   Measured: through study completion, average 2 months

6. Dizziness Handicap Inventory (DHI)

   It is used to determine the physical, sensory and functional effects of vestibular system pathologies. Questions 1, 4, 8, 11, 13, 17 and 25 measure physical disability; questions 2, 9, 10, 15, 18, 20, 21, 22 and 23 measure emotional disability; questions 3, 5, 6, 7, 12, 14, 16, 19 and 24 measure functional disability. Each question consists of yes (4 points), no (0 points) and sometimes (2) answers. In scoring the subunits of the inventory, 28 points were accepted as the limit to determine physical disability and 36 points as the limit to determine functional and sensory disability. High scores indicate that the patient's dizziness complaint is at an advanced level.

   Measured: through study completion, average 2 months

7. Tampa Kinesiophobia Scale (TKS)

   A 4-point Likert scale (1 = I completely disagree, 4 = I completely agree) is used. It consists of 17 questions. The total score is calculated after reversing items 4, 8, 12 and 16. It gets a total score between 17-68. A high score indicates that kinesiophobia is also high.

   Measured: through study completion, average 2 months

8. Static Posture Assessment with ICS

   The Limit of Stability (LOS) program in the balance device called "Otometrics ICS Balance Platform" evaluates the points that the body reaches to maintain balance, the speed of movement and direct control in 8 directions. These directions are; front, right-front, right, right-back, back, left-back, left, left-front. The LOS test measures the maximum distance that an individual can consciously change their center of gravity and extend their body in a certain direction without losing their balance and without taking a step.

   Measured: through study completion, average 2 months

9. Videonystagmography (VNG)

   It allows the evaluation of eye movements via cameras sensitive to infrared rays. It is a complex test that allows the examination of the inner ear, including many tests. The test includes; saccade, gaze, tracking, optokinetic, positional tests, Dix Hallpike maneuver and bithermal caloric test. Caloric test is known as the gold standard for the diagnosis of vestibular hypofunction. It reveals the degree, location of hypofunction, whether it is central or peripheral. During the caloric test, thermal stimuli are given and the vestibulo-ocular reflex is evaluated and the pathology is found on which side. 8 liters of air with 50 degrees and 24 degrees temperature, respectively, is sent to the eardrum in 60 seconds with 5-minute rest intervals in both ears. Involuntary eye movements are recorded, calculated and graphed for 120-140 seconds. While evaluating the test result; the onset time of nystagmus, its speed and the possibility of suppression with fixation are examined.

   Measured: through study completion, average 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Aug 2024
2. Study start1 Dec 2021
3. Primary completion1 Apr 2022
4. Study completion1 Dec 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for VideonystagmographyStudies of the same condition, open and under way.
• 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.