Vestibular Nerve DiseasesNCT04396132
The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
A study testing Subjective Visual Vertical with Virtual SVV instrument in people with Vestibular Nerve Diseases, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The sense of gravity is one of the important input of our balance system. The utricle is the key structure on this subject but the contribution of the proprioceptive receptors is also important. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Nerve Diseases
- What is being tested?
- Subjective Visual Vertical with Virtual SVV instrument
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2020to 30 Jul 2020
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No ear disease
- No neurologic disease
- No surgery for ear, brain or musculoskeletal system
Who cannot join
- Diabetes mellitus
- Drug use effective on central nervous system
Trial locations and contacts
1 site in 1 country.
About this study
The sense of gravity is one of the important input of our balance system. The utricle is the key structure on this subject but the contribution of the proprioceptive receptors is also important. The aim of this study is to measure the effect of different angles of head tilt and soft surface on SVV in healthy subjects with a new automated system.
Read the detailed description
Two different settings will be used. In the first experiment, healthy subjects will make 15, 30, and 45-degree head tilt to the left and right side while they are standing. In every position, 3 measurements will be done. In the second experiment, 40 health subjects will make the same head maneuvers on the 20 cm thick soft surface. We will compare the effects of both head tilt and soft surface. All measurements will be done with a virtual SVV system(Interacoustics).
- Conditions
- Vestibular Nerve Diseases
- Being tested
- Subjective Visual Vertical with Virtual SVV instrument
- Medical subject headings
- Vestibulocochlear Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjective Visual Vertical with Virtual SVV instrumentDiagnostic test
The deviation angle will be measured with 15, 30 and 45-degree head tilt to the left and right side while they are standing
| Study group | Role | What they receive |
|---|---|---|
| Virtual SVV | Experimental | The subjects will be tested by virtual SVV. The deviation angle will be measured at 15, 30 and 45-degree head tilt to the left and right side while they are standing Receives: Diagnostic Test: Subjective Visual Vertical with Virtual SVV instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Visual Vertical
The measurement of deviation angle with 15, 30 and 45-degree head tilt to the left and right side while they are standing
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start21 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular Nerve DiseasesStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
- Investigators
- Fazıl N Ardıç, MD, Principal investigator, Department Of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396132
- Sponsor's protocol ID
- 4
- Status last verified
- Jun 2022
- First submitted
- 17 May 2020
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared from university depository
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
- ClinicalTrials.gov ID
- NCT04396132
- Acronym / sponsor ID
- 4
- Conditions
- Vestibular Nerve Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 20 May 2020 (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.
The sense of gravity is one of the important input of our balance system. The utricle is the key structure on this subject but the contribution of the proprioceptive receptors is also important. The aim of this study is to measure the effect of different angles of head tilt and soft surface on SVV in healthy subjects with a new automated system.
Detailed description
Two different settings will be used. In the first experiment, healthy subjects will make 15, 30, and 45-degree head tilt to the left and right side while they are standing. In every position, 3 measurements will be done. In the second experiment, 40 health subjects will make the same head maneuvers on the 20 cm thick soft surface. We will compare the effects of both head tilt and soft surface. All measurements will be done with a virtual SVV system(Interacoustics).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual SVV | Experimental | Diagnostic Test: Subjective Visual Vertical with Virtual SVV instrumentThe subjects will be tested by virtual SVV. The deviation angle will be measured at 15, 30 and 45-degree head tilt to the left and right side while they are standing |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No ear disease
- No neurologic disease
- No surgery for ear, brain or musculoskeletal system
Key exclusion criteria (2 listed)
- Diabetes mellitus
- Drug use effective on central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjective Visual Vertical with Virtual SVV instrumentThe deviation angle will be measured with 15, 30 and 45-degree head tilt to the left and right side while they are standing | Diagnostic test | Virtual SVV |
Primary outcome
Subjective Visual Vertical
Time frame: 1 month
The measurement of deviation angle with 15, 30 and 45-degree head tilt to the left and right side while they are standing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No. Data will be shared from university depository
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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.
Fazıl N Ardıç, MD principal investigator
Department Of Otolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subjective Visual Vertical with Virtual SVV instrument in people with Vestibular Nerve Diseases, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jun 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective Visual Vertical (time frame: 1 month). 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 14 Jun 2022.