Benign Paroxysmal Positional Vertigo (Disorder)NCT05333198

Oculomotor and Vestibular Ocular Reflex Exercises in Patients With Benign Paroxysmal Positional Vertigo

A study testing Traditional physical therapy using Epley's maneuver and Oculomotor and Vestibular Ocular Reflex (VOR) exercises in people with Benign Paroxysmal Positional Vertigo (Disorder), run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Benign Paroxysmal Positional Vertigo (Disorder)
What is being tested?: Traditional physical therapy using Epley's maneuver and Oculomotor and Vestibular Ocular Reflex (VOR) exercises
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 sitePakistan
Study dates: 15 Feb 2021to 15 Dec 2021
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 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients who have vertigo with posterior canal involvement during Dix-Hallpike test with or without accompanying nystagmus (objective or subjective BPPV).
Ability to walk at least 3 meters by itself with or without assistive device
Normal vision with or without correction by spectacles or contact lenses

Who cannot join

Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases to eliminate confounding factors affecting balance performance
Unable to understand and answer a simple verbal command.
Previously underwent oculomotor and vestibular ocular exercises.
Other vestibular disorders like Meniere disease
Long-term use of benzodiazepines (more than 20 years).
Patients who are already performing structured physical activities such as muscle strengthening exercises, Pilates, yoga or high intensity aerobic exercises

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Binash Afzal
Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effects of Oculomotor and Vestibular Ocular Reflex Exercises on Vertigo, Dizziness and Balance in Patients With Benign Paroxysmal Positional Vertigo

The aim of this research is to assess effects of Oculomotor and VOR exercises on vertigo, dizziness and balance in patients with BPPV. Randomized controlled trial was conducted at Hameed Latif Hospital, Lahore. The sample size 32 participants which were divided into two groups, 16 participants in traditional physical therapy group and 16 in oculomotor and vestibular ocular reflex exercises group. Study duration was of 6 months. Sampling technique applied was non-probability consecutive sampling technique. Only 30-70 years individuals with Benign Paroxysmal Positional Vertigo (BPPV) were included. Tools used in the study are vertigo handicap questionnaire, visual vertigo analogue scale, dizziness handicap inventory, berg balance scale and dynamic gait index. The data was analyzed using SPSS.

Read the detailed description

Randomized controlled trial was conducted at Hameed Latif Hospital, Lahore. The sample size 32 participants which were divided into two groups, 16 participants in traditional physical therapy group and 16 in oculomotor and vestibular ocular reflex exercises group. Study duration was of 6 months. Sampling technique applied was non-probability consecutive sampling technique. Only 30-70 years individuals with Benign Paroxysmal Positional Vertigo (BPPV) were included. Tools used in the study are vertigo handicap questionnaire, visual vertigo analogue scale, dizziness handicap inventory, berg balance scale and dynamic gait index. The data was analyzed using SPSS.

Conditions: Benign Paroxysmal Positional Vertigo (Disorder)
Being tested: Traditional physical therapy using Epley's maneuver, Oculomotor and Vestibular Ocular Reflex (VOR) exercises
Keywords: Benign Paroxysmal Positional Vertigo, Oculomotor exercises, Vestibular Ocular Reflex (VOR) exercises
Medical subject headings: Benign Paroxysmal Positional Vertigo, Motor Activity

What participants receive

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

Traditional physical therapy using Epley's maneuverOther
Epley's maneuver was performed once a week for three weeks. The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side. Each position was maintained for 1-2 minutes.
Oculomotor and Vestibular Ocular Reflex (VOR) exercisesOther
oculomotor and VOR exercises after Epley's maneuver. The exercises were performed for approximately 5 minutes daily or 1 to 2 minutes, 3 to 4 times a day, in sitting position. The exercises were continued for three weeks. The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side. Each position was maintained for 1-2 minutes. Saccadic exercises were performed by moving eyes between two stationary targets. Smooth pursuit exercises were performed by tracking a moving target while keeping head still and VOR exercises were performed by moving head left to right while maintaining eyes on stationary target

Study groups in NCT05333198
Study group	Role	What they receive
Traditional physical therapy using Epley's maneuver	Other	Epley's maneuver was performed once a week for three weeks. The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side. Each position was maintained for 1-2 minutes. Receives: Other: Traditional physical therapy using Epley's maneuver
Oculomotor and Vestibular Ocular Reflex (VOR) exercises	Active comparator	oculomotor and VOR exercises after Epley's maneuver. The exercises were performed for approximately 5 minutes daily or 1 to 2 minutes, 3 to 4 times a day, in sitting position. The exercises were continued for three weeks. The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side. Each position was maintained for 1-2 minutes. Saccadic exercises were performed by moving eyes between two stationary targets. Smooth pursuit exercises were performed by tracking a moving target while keeping head still and VOR exercises were performed by moving head left to right while maintaining eyes on stationary target Receives: Other: Oculomotor and Vestibular Ocular Reflex (VOR) exercises

What is being measured

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

Vertigo Handicap Questionnaire
It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.
Measured: First reading at 0 day
Vertigo Handicap Questionnaire
It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.
Measured: second reading after 3 weeks
Visual Vertigo Analogue Scale
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness
Measured: First reading at 0 day
Visual Vertigo Analogue Scale
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness
Measured: second reading after 3 weeks
Dizziness Handicap Inventory
Self-perceived handicapping effects imposed by dizziness.
Measured: First reading at 0 day
Dizziness Handicap Inventory
Self-perceived handicapping effects imposed by dizziness.
Measured: second reading after 3 weeks
Berg Balance Scale
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
Measured: First reading at 0 day
Berg Balance Scale
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
Measured: First reading at 3 week
Dynamic Gait Index
The clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks.
Measured: first reading after 0 day
Dynamic Gait Index
The clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks.
Measured: second reading after 3 weeks

Timeline

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

15 Feb 202115 Dec 2021

First posted18 Apr 2022
Study start15 Feb 2021
Primary completion15 Oct 2021
Study completion15 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Benign Paroxysmal Positional Vertigo (Disorder)Studies of the same condition, open and under way.
More trials run by Riphah International 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05333198
Sponsor's protocol ID: RiphahIU Ezza Zikrea
Status last verified: Apr 2022
First submitted: 21 Jan 2022
Last updated: 18 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kim HJ, Lee JO, Choi JY, Kim JS. Etiologic distribution of dizziness and vertigo in a referral-based dizziness clinic in South Korea. J Neurol. 2020 Aug;267(8):2252-2259. doi: 10.1007/s00415-020-09831-2. Epub 2020 Apr 16.
PubMed 32300888
Scocco DH, Garcia IE, Barreiro MA. Sitting Up Vertigo. Proposed Variant of Posterior Canal Benign Paroxysmal Positional Vertigo. Otol Neurotol. 2019 Apr;40(4):497-503. doi: 10.1097/MAO.0000000000002157.
PubMed 30870365
Dunlap PM, Holmberg JM, Whitney SL. Vestibular rehabilitation: advances in peripheral and central vestibular disorders. Curr Opin Neurol. 2019 Feb;32(1):137-144. doi: 10.1097/WCO.0000000000000632.
PubMed 30461465
Wu P, Cao W, Hu Y, Li H. Effects of vestibular rehabilitation, with or without betahistine, on managing residual dizziness after successful repositioning manoeuvres in patients with benign paroxysmal positional vertigo: a protocol for a randomised controlled trial. BMJ Open. 2019 Jun 18;9(6):e026711. doi: 10.1136/bmjopen-2018-026711.
PubMed 31217316
Kane AW, Diaz DS, Moore C. Physical Therapy Management of Adults with Mild Traumatic Brain Injury. Semin Speech Lang. 2019 Feb;40(1):36-47. doi: 10.1055/s-0038-1676652. Epub 2019 Jan 7.
PubMed 30616293
Hillier S, McDonnell M. Is vestibular rehabilitation effective in improving dizziness and function after unilateral peripheral vestibular hypofunction? An abridged version of a Cochrane Review. Eur J Phys Rehabil Med. 2016 Aug;52(4):541-56. Epub 2016 Jul 12.
PubMed 27406654
Arnold SA, Stewart AM, Moor HM, Karl RC, Reneker JC. The Effectiveness of Vestibular Rehabilitation Interventions in Treating Unilateral Peripheral Vestibular Disorders: A Systematic Review. Physiother Res Int. 2017 Jul;22(3). doi: 10.1002/pri.1635. Epub 2015 Jun 25.
PubMed 26111348
Meldrum D, Burrows L, Cakrt O, Kerkeni H, Lopez C, Tjernstrom F, Vereeck L, Zur O, Jahn K. Vestibular rehabilitation in Europe: a survey of clinical and research practice. J Neurol. 2020 Dec;267(Suppl 1):24-35. doi: 10.1007/s00415-020-10228-4. Epub 2020 Oct 13.
PubMed 33048219
Mempouo E, Lau K, Green F, Bowes C, Ray J. Customised vestibular rehabilitation with the addition of virtual reality based therapy in the management of persistent postural-perceptual dizziness. J Laryngol Otol. 2021 Oct;135(10):887-891. doi: 10.1017/S0022215121002127. Epub 2021 Aug 10.
PubMed 34372958
Lin SI, Tsai YJ, Lee PY. Balance performance when responding to visual stimuli in patients with Benign Paroxysmal Positional Vertigo (BPPV). J Vestib Res. 2020;30(4):267-274. doi: 10.3233/VES-200709.
PubMed 32925126

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
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Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
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Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
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Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
Vertigo Benign Positional, Dizziness
Active, not recruiting
Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme
Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction

All Benign Paroxysmal Positional Vertigo (Disorder) trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Oculomotor and Vestibular Ocular Reflex Exercises on Vertigo, Dizziness and Balance in Patients With Benign Paroxysmal Positional Vertigo
ClinicalTrials.gov ID: NCT05333198
Acronym / sponsor ID: RiphahIU Ezza Zikrea
Conditions: Benign Paroxysmal Positional Vertigo (Disorder)
Keywords: Benign Paroxysmal Positional Vertigo, Oculomotor exercises, Vestibular Ocular Reflex (VOR) exercises
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 15 Feb 2021 (actual)
Primary completion: 15 Oct 2021 (actual)
Study completion: 15 Dec 2021 (actual)
First posted: 18 Apr 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Traditional physical therapy using Epley's maneuver	Other	Other: Traditional physical therapy using Epley's maneuverEpley's maneuver was performed once a week for three weeks. The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side. Each position was maintained for 1-2 minutes.
Oculomotor and Vestibular Ocular Reflex (VOR) exercises	Active comparator	Other: Oculomotor and Vestibular Ocular Reflex (VOR) exercisesoculomotor and VOR exercises after Epley's maneuver. The exercises were performed for approximately 5 minutes daily or 1 to 2 minutes, 3 to 4 times a day, in sitting position. The exercises were continued for three weeks. The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side. Each position was maintained for 1-2 minutes. Saccadic exercises were performed by moving eyes between two stationary targets. Smooth pursuit exercises were performed by tracking a moving target while keeping head still and VOR exercises were performed by moving head left to right while maintaining eyes on stationary target

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Patients who have vertigo with posterior canal involvement during Dix-Hallpike test with or without accompanying nystagmus (objective or subjective BPPV).
Ability to walk at least 3 meters by itself with or without assistive device
Normal vision with or without correction by spectacles or contact lenses

Key exclusion criteria (6 listed)

Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases to eliminate confounding factors affecting balance performance
Unable to understand and answer a simple verbal command.
Previously underwent oculomotor and vestibular ocular exercises.
Other vestibular disorders like Meniere disease
Long-term use of benzodiazepines (more than 20 years).

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
Traditional physical therapy using Epley's maneuverEpley's maneuver was performed once a week for three weeks. The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side. Each position was maintained for 1-2 minutes.	Other	Traditional physical therapy using Epley's maneuver
Oculomotor and Vestibular Ocular Reflex (VOR) exercisesoculomotor and VOR exercises after Epley's maneuver. The exercises were performed for approximately 5 minutes daily or 1 to 2 minutes, 3 to 4 times a day, in sitting position. The exercises were continued for three weeks. The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side. Each position was maintained for 1-2 minutes. Saccadic exercises were performed by moving eyes between two stationary targets. Smooth pursuit exercises were performed by tracking a moving target while keeping head still and VOR exercises were performed by moving head left to right while maintaining eyes on stationary target	Other	Oculomotor and Vestibular Ocular Reflex (VOR) exercises

Primary outcome

Vertigo Handicap Questionnaire
Time frame: First reading at 0 day
It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.
Vertigo Handicap Questionnaire
Time frame: second reading after 3 weeks
It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.
Visual Vertigo Analogue Scale
Time frame: First reading at 0 day
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness
Visual Vertigo Analogue Scale
Time frame: second reading after 3 weeks
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness
Dizziness Handicap Inventory
Time frame: First reading at 0 day
Self-perceived handicapping effects imposed by dizziness.
Dizziness Handicap Inventory
Time frame: second reading after 3 weeks
Self-perceived handicapping effects imposed by dizziness.
Berg Balance Scale
Time frame: First reading at 0 day
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
Berg Balance Scale
Time frame: First reading at 3 week
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
Dynamic Gait Index
Time frame: first reading after 0 day
The clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks.
Dynamic Gait Index
Time frame: second reading after 3 weeks
The clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks.

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 18 Apr 2022.
Background: PubMed 32300888Kim HJ, Lee JO, Choi JY, Kim JS. Etiologic distribution of dizziness and vertigo in a referral-based dizziness clinic in South Korea. J Neurol. 2020 Aug;267(8):2252-2259. doi: 10.1007/s00415-020-09831-2. Epub 2020 Apr 16.
Background: PubMed 30870365Scocco DH, Garcia IE, Barreiro MA. Sitting Up Vertigo. Proposed Variant of Posterior Canal Benign Paroxysmal Positional Vertigo. Otol Neurotol. 2019 Apr;40(4):497-503. doi: 10.1097/MAO.0000000000002157.
Background: PubMed 30461465Dunlap PM, Holmberg JM, Whitney SL. Vestibular rehabilitation: advances in peripheral and central vestibular disorders. Curr Opin Neurol. 2019 Feb;32(1):137-144. doi: 10.1097/WCO.0000000000000632.
Background: PubMed 31217316Wu P, Cao W, Hu Y, Li H. Effects of vestibular rehabilitation, with or without betahistine, on managing residual dizziness after successful repositioning manoeuvres in patients with benign paroxysmal positional vertigo: a protocol for a randomised controlled trial. BMJ Open. 2019 Jun 18;9(6):e026711. doi: 10.1136/bmjopen-2018-026711.
Background: PubMed 30616293Kane AW, Diaz DS, Moore C. Physical Therapy Management of Adults with Mild Traumatic Brain Injury. Semin Speech Lang. 2019 Feb;40(1):36-47. doi: 10.1055/s-0038-1676652. Epub 2019 Jan 7.
Background: PubMed 27406654Hillier S, McDonnell M. Is vestibular rehabilitation effective in improving dizziness and function after unilateral peripheral vestibular hypofunction? An abridged version of a Cochrane Review. Eur J Phys Rehabil Med. 2016 Aug;52(4):541-56. Epub 2016 Jul 12.
Background: PubMed 26111348Arnold SA, Stewart AM, Moor HM, Karl RC, Reneker JC. The Effectiveness of Vestibular Rehabilitation Interventions in Treating Unilateral Peripheral Vestibular Disorders: A Systematic Review. Physiother Res Int. 2017 Jul;22(3). doi: 10.1002/pri.1635. Epub 2015 Jun 25.
Background: PubMed 33048219Meldrum D, Burrows L, Cakrt O, Kerkeni H, Lopez C, Tjernstrom F, Vereeck L, Zur O, Jahn K. Vestibular rehabilitation in Europe: a survey of clinical and research practice. J Neurol. 2020 Dec;267(Suppl 1):24-35. doi: 10.1007/s00415-020-10228-4. Epub 2020 Oct 13.
Background: PubMed 34372958Mempouo E, Lau K, Green F, Bowes C, Ray J. Customised vestibular rehabilitation with the addition of virtual reality based therapy in the management of persistent postural-perceptual dizziness. J Laryngol Otol. 2021 Oct;135(10):887-891. doi: 10.1017/S0022215121002127. Epub 2021 Aug 10.
Background: PubMed 32925126Lin SI, Tsai YJ, Lee PY. Balance performance when responding to visual stimuli in patients with Benign Paroxysmal Positional Vertigo (BPPV). J Vestib Res. 2020;30(4):267-274. doi: 10.3233/VES-200709.
Individual participant dataSharing planned: No

Related trials for Benign Paroxysmal Positional Vertigo (Disorder)

Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
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Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
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Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
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Not yet recruiting
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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.

Binash Afzal, PhD* principal investigator

Riphah International University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 18 Apr 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 Pakistan. 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?

Vertigo Handicap Questionnaire (time frame: First reading at 0 day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05333198, which also lists 10 linked publications.

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 18 Apr 2022.