VertigoNCT07238387
Evaluation of Nystagmus Examination Using Wearable AR Glasses in Vertigo Patients
A study testing Wearable Augmented Reality Glasses for Nystagmus Examination and Conventional Nystagmus Examination in people with Vertigo and Vestibular Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background and Purpose: Vertigo is common in emergency and outpatient settings, yet standard oculomotor testing usually requires dedicated equipment and exam rooms. This study evaluates whether nystagmus examinations performed with wearable augmented-reality (AR) glasses are equivalent to conventional examination-room… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertigo, Vestibular Disorder, Nystagmus
- What is being tested?
- Wearable Augmented Reality Glasses for Nystagmus Examination and Conventional Nystagmus Examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years with vertigo/dizziness suggestive of a central or peripheral vestibular disorder.
- Able to complete both AR-based and conventional oculomotor testing during the same visit (with ~30-minute washout).
- Provide written informed consent.
- Adequate vision for eye-tracking and calibration (e.g., corrected visual acuity ≥20/40 in each eye).
- Willing and able to return for the follow-up visit.
Who cannot join
- Use of vestibular-suppressant medications within 24 hours prior to testing (e.g., benzodiazepines, antihistamines, anticholinergics).
- Ocular conditions that would interfere with reliable eye tracking (e.g., corrected visual acuity <20/40, dense cataract, severe ptosis/strabismus, active ocular infection/inflammation).
- History of photosensitive epilepsy or seizure disorder triggered by visual stimuli.
- Severe motion sickness/cybersickness or inability to tolerate the AR headset.
- Significant cognitive impairment or psychiatric condition precluding informed consent or protocol compliance.
- Pregnant or breastfeeding (per investigator judgment and IRB policy).
- Any other condition that, in the investigator's opinion, would make participation unsafe or confound study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
Ching-Nung Wu, 0913684642, taytay@cgmh.org.tw
About this study
Official title: Evaluation of Nystagmus Examinations Conducted Using Wearable Augmented Reality Glasses in Vertigo Patients: A Randomized Equivalence Study
Background and Purpose:
Vertigo is common in emergency and outpatient settings, yet standard oculomotor testing usually requires dedicated equipment and exam rooms. This study evaluates whether nystagmus examinations performed with wearable augmented-reality (AR) glasses are equivalent to conventional examination-room testing for classifying central vs. peripheral vertigo. The investigators also assess diagnostic accuracy, patient tolerability, and the reliability of AR-based interpretation (test-retest and inter-rater).
Read more
Study Design:
Prospective, single-center, within-subject randomized equivalence study at Kaohsiung Chang Gung Memorial Hospital. Each participant completes both AR-based and conventional oculomotor testing in a randomized order during the same visit, separated by a 30-minute washout. The study uses an evaluator-blind approach: de-identified trajectories are reviewed offline by independent experts who are masked to test modality. A follow-up visit (~1 week) captures adverse events and patient experience.
Participants:
Adults (≥18 years) presenting with vertigo who can tolerate the AR headset and provide consent. Key exclusions include conditions that prevent reliable eye-tracking (e.g., corrected visual acuity <20/40), recent use of vestibular suppressants (within 24 hours), and other factors limiting cooperation or safety.
Interventions and Procedures:
The AR system records eye movements and presents standardized visual stimuli. Conventional testing follows current clinical standards (e.g., Frenzel/oculomotor exam). All recordings are stored securely for blinded review.
Outcomes:
Primary endpoint: Equivalence of diagnostic agreement (central vs. peripheral) between AR-based and conventional methods, quantified by Cohen's kappa (κ) with a predefined equivalence margin.
Secondary endpoints: (1) Diagnostic accuracy of the AR method in a clinically-indicated imaging subgroup (MRI preferred; CT as needed) using a sequential evaluation strategy; (2) Patient discomfort/tolerability using VAS and CSQ-VR, compared between modalities; (3) Test-retest reliability of AR-based classifications; (4) Inter-rater reliability between independent evaluators, with a third reader adjudicating discordant cases; (5) prespecified subgroup analyses by age, medical history, and vestibular function.
Sample Size and Duration:
Approximately 200 participants will be enrolled (target ~180 evaluable after ~10% attrition). Total study duration is ~2 years, including enrollment, follow-up, and analysis.
Risks and Benefits:
Both tests are non-invasive. Potential transient discomfort (e.g., eye strain or cybersickness) will be monitored. There may be no direct benefit to participants; however, results could support broader, more accessible, and standardized vertigo assessment.
Data Security and Privacy:
All data are de-identified, stored on secure platforms with role-based access and audit trails. Safety events are monitored and graded, and protocol deviations are handled per Good Clinical Practice.
- Conditions
- Vertigo, Vestibular Disorder, Nystagmus
- Being tested
- Wearable Augmented Reality Glasses for Nystagmus Examination, Conventional Nystagmus Examination
- Medical subject headings
- Vertigo, Vestibular Diseases, Nystagmus, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Augmented Reality Glasses for Nystagmus ExaminationDevice
Intervention 1 - Wearable Augmented Reality Glasses for Nystagmus Examination Participants undergo a standardized nystagmus examination using wearable augmented reality (AR) glasses equipped with an integrated eye-tracking system. The AR-based system records real-time eye movements in both light and dark conditions, allowing for simultaneous examiner visualization and data storage. This method eliminates the need for traditional Frenzel goggles and provides automated signal quality assessment.
Conventional Nystagmus ExaminationDevice
Intervention 2 - Conventional Nystagmus Examination Participants undergo a conventional clinical nystagmus examination performed by an otolaryngologist using standard Frenzel goggles under similar test conditions. Eye movements are visually assessed without integrated digital recording or automated signal analysis.
| Study group | Role | What they receive |
|---|---|---|
| AR-First Examination Sequence | Experimental | AR-based examination first, then conventional examination Receives: Device: Wearable Augmented Reality Glasses for Nystagmus Examination; Device: Conventional Nystagmus Examination |
| Conventional-First Examination Sequence | Active comparator | Conventional examination first, then AR-based examination Receives: Device: Wearable Augmented Reality Glasses for Nystagmus Examination; Device: Conventional Nystagmus Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence of Diagnostic Agreement (Central vs Peripheral) Between AR-Based and Conventional Examinations, Assessed by Cohen's Kappa
Cohen's Kappa (κ) will be used to evaluate diagnostic agreement between AR-based and conventional examinations. κ ranges from -1.0 to 1.0, where 1.0 indicates perfect agreement, 0 indicates chance-level agreement, and negative values indicate worse-than-chance agreement. Higher κ values represent better diagnostic consistency.
Measured: Day 1 (immediately after completion of both AR-based and conventional examinations)
Secondary outcomes (5)
Diagnostic Accuracy of AR-Based Examination Compared to Neuroimaging (Sensitivity, Specificity, PPV, NPV)
Measured: Within 30 days after Day 1 (baseline examination), for participants undergoing clinically indicated MRI (preferred) or CT
Test-Retest Reliability of AR-Based Examination (Cohen's Kappa)
Test-retest reliability of AR-based examination will be assessed using Cohen's Kappa coefficient (κ). κ ranges from -1.0 to 1.0, where 1.0 indicates perfect agreement, 0 indicates chance-level agreement, and negative values indicate worse-than-chance agreement. Higher κ values indicate better reliability.
Measured: Day 1 - within 1 hour after completion of the initial AR-based examination
Patient Discomfort Measured by Visual Analog Scale (VAS)
Visual Analog Scale (VAS) will be used to assess patient-reported discomfort immediately after each test. The VAS ranges from 0 to 10, where 0 indicates no discomfort and 10 indicates the worst imaginable discomfort. Higher scores represent greater discomfort.
Measured: Day 1 - immediately after completion of AR-based and conventional examinations
Patient Discomfort Measured by Cybersickness Questionnaire for Virtual Reality (CSQ-VR)
Patient discomfort will also be measured using the Cybersickness Questionnaire for Virtual Reality (CSQ-VR). The CSQ-VR assesses cybersickness symptoms across multiple domains (e.g., nausea, oculomotor strain, disorientation). Scores range from 6 to 42, with higher scores indicating more severe discomfort.
Measured: Day 1 - immediately after completion of AR-based and conventional examinations
Inter-Rater Reliability of Diagnostic Interpretations (Cohen's Kappa; Fleiss' Kappa if applicable)
Inter-rater reliability of diagnostic interpretations will be assessed using Cohen's Kappa coefficient (κ) for two raters, and Fleiss' Kappa for three or more raters.
Cohen's Kappa (κ): Ranges from -1.0 to 1.0, where 1.0 indicates perfect agreement, 0 indicates agreement equivalent to chance, and negative values indicate worse-than-chance agreement. Higher values represent better inter-rater reliability.
Fleiss' Kappa: Ranges from -1.0 to 1.0, with the same interpretation as Cohen's Kappa.
Measured: Following Day 1 (baseline visit), blinded offline review of examination recordings prior to database lock
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238387
- Sponsor's protocol ID
- 202500606B0
- Status last verified
- Aug 2025
- First submitted
- 16 Sep 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcome results will be made available to qualified researchers upon reasonable request. Data will be shared beginning 6 months after publication of the main results and for up to 5 years thereafter. Requests should be directed to the principal investigator via institutional email and must include a methodologically sound proposal and a signed data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nystagmus Examinations Conducted Using Wearable Augmented Reality Glasses in Vertigo Patients: A Randomized Equivalence Study
- ClinicalTrials.gov ID
- NCT07238387
- Acronym / sponsor ID
- 202500606B0
- Conditions
- Vertigo, Vestibular Disorder, Nystagmus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Nov 2025 (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.
Background and Purpose:
Vertigo is common in emergency and outpatient settings, yet standard oculomotor testing usually requires dedicated equipment and exam rooms. This study evaluates whether nystagmus examinations performed with wearable augmented-reality (AR) glasses are equivalent to conventional examination-room testing for classifying central vs. peripheral vertigo. The investigators also assess diagnostic accuracy, patient tolerability, and the reliability of AR-based interpretation (test-retest and inter-rater).
Study Design:
Prospective, single-center, within-subject randomized equivalence study at Kaohsiung Chang Gung Memorial Hospital. Each participant completes both AR-based and conventional oculomotor testing in a randomized order during the same visit, separated by a 30-minute washout. The study uses an evaluator-blind approach: de-identified trajectories are reviewed offline by independent experts who are masked to test modality. A follow-up visit (~1 week) captures adverse events and patient experience.
Participants:
Adults (≥18 years) presenting with vertigo who can tolerate the AR headset and provide consent. Key exclusions include conditions that prevent reliable eye-tracking (e.g., corrected visual acuity <20/40), recent use of vestibular suppressants (within 24 hours), and other factors limiting cooperation or safety.
Interventions and Procedures:
The AR system records eye movements and presents standardized visual stimuli. Conventional testing follows current clinical standards (e.g., Frenzel/oculomotor exam). All recordings are stored securely for blinded review.
Outcomes:
Primary endpoint: Equivalence of diagnostic agreement (central vs. peripheral) between AR-based and conventional methods, quantified by Cohen's kappa (κ) with a predefined equivalence margin.
Secondary endpoints: (1) Diagnostic accuracy of the AR method in a clinically-indicated imaging subgroup (MRI preferred; CT as needed) using a sequential evaluation strategy; (2) Patient discomfort/tolerability using VAS and CSQ-VR, compared between modalities; (3) Test-retest reliability of AR-based classifications; (4) Inter-rater reliability between independent evaluators, with a third reader adjudicating discordant cases; (5) prespecified subgroup analyses by age, medical history, and vestibular function.
Sample Size and Duration:
Approximately 200 participants will be enrolled (target ~180 evaluable after ~10% attrition). Total study duration is ~2 years, including enrollment, follow-up, and analysis.
Risks and Benefits:
Both tests are non-invasive. Potential transient discomfort (e.g., eye strain or cybersickness) will be monitored. There may be no direct benefit to participants; however, results could support broader, more accessible, and standardized vertigo assessment.
Data Security and Privacy:
All data are de-identified, stored on secure platforms with role-based access and audit trails. Safety events are monitored and graded, and protocol deviations are handled per Good Clinical Practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR-First Examination Sequence | Experimental | Device: Wearable Augmented Reality Glasses for Nystagmus Examination, Device: Conventional Nystagmus ExaminationAR-based examination first, then conventional examination |
| Conventional-First Examination Sequence | Active comparator | Device: Wearable Augmented Reality Glasses for Nystagmus Examination, Device: Conventional Nystagmus ExaminationConventional examination first, then AR-based examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥18 years with vertigo/dizziness suggestive of a central or peripheral vestibular disorder.
- Able to complete both AR-based and conventional oculomotor testing during the same visit (with ~30-minute washout).
- Provide written informed consent.
- Adequate vision for eye-tracking and calibration (e.g., corrected visual acuity ≥20/40 in each eye).
- Willing and able to return for the follow-up visit.
Key exclusion criteria (7 listed)
- Use of vestibular-suppressant medications within 24 hours prior to testing (e.g., benzodiazepines, antihistamines, anticholinergics).
- Ocular conditions that would interfere with reliable eye tracking (e.g., corrected visual acuity <20/40, dense cataract, severe ptosis/strabismus, active ocular infection/inflammation).
- History of photosensitive epilepsy or seizure disorder triggered by visual stimuli.
- Severe motion sickness/cybersickness or inability to tolerate the AR headset.
- Significant cognitive impairment or psychiatric condition precluding informed consent or protocol compliance.
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 |
|---|---|---|
| Wearable Augmented Reality Glasses for Nystagmus ExaminationIntervention 1 - Wearable Augmented Reality Glasses for Nystagmus Examination Participants undergo a standardized nystagmus examination using wearable augmented reality (AR) glasses equipped with an integrated eye-tracking system. The AR-based system records real-time eye movements in both light and dark conditions, allowing for simultaneous examiner visualization and data storage. This method eliminates the need for traditional Frenzel goggles and provides automated signal quality assessment. | Device | AR-First Examination Sequence, Conventional-First Examination Sequence |
| Conventional Nystagmus ExaminationIntervention 2 - Conventional Nystagmus Examination Participants undergo a conventional clinical nystagmus examination performed by an otolaryngologist using standard Frenzel goggles under similar test conditions. Eye movements are visually assessed without integrated digital recording or automated signal analysis. | Device | AR-First Examination Sequence, Conventional-First Examination Sequence |
Primary outcome
Equivalence of Diagnostic Agreement (Central vs Peripheral) Between AR-Based and Conventional Examinations, Assessed by Cohen's Kappa
Time frame: Day 1 (immediately after completion of both AR-based and conventional examinations)
Cohen's Kappa (κ) will be used to evaluate diagnostic agreement between AR-based and conventional examinations. κ ranges from -1.0 to 1.0, where 1.0 indicates perfect agreement, 0 indicates chance-level agreement, and negative values indicate worse-than-chance agreement. Higher κ values represent better diagnostic consistency.
5 secondary outcomes
Diagnostic Accuracy of AR-Based Examination Compared to Neuroimaging (Sensitivity, Specificity, PPV, NPV)
Time frame: Within 30 days after Day 1 (baseline examination), for participants undergoing clinically indicated MRI (preferred) or CT
Test-Retest Reliability of AR-Based Examination (Cohen's Kappa)
Time frame: Day 1 - within 1 hour after completion of the initial AR-based examination
Patient Discomfort Measured by Visual Analog Scale (VAS)
Time frame: Day 1 - immediately after completion of AR-based and conventional examinations
Patient Discomfort Measured by Cybersickness Questionnaire for Virtual Reality (CSQ-VR)
Time frame: Day 1 - immediately after completion of AR-based and conventional examinations
Inter-Rater Reliability of Diagnostic Interpretations (Cohen's Kappa; Fleiss' Kappa if applicable)
Time frame: Following Day 1 (baseline visit), blinded offline review of examination recordings prior to database lock
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary and secondary outcome results will be made available to qualified researchers upon reasonable request. Data will be shared beginning 6 months after publication of the main results and for up to 5 years thereafter. Requests should be directed to the principal investigator via institutional email and must include a methodologically sound proposal and a signed data use agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Augmented Reality Glasses for Nystagmus Examination and Conventional Nystagmus Examination in people with Vertigo and Vestibular Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-Nung Wu, MD, PhD (+886975369260, taytay@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence of Diagnostic Agreement (Central vs Peripheral) Between AR-Based and Conventional Examinations, Assessed by Cohen's Kappa (time frame: Day 1 (immediately after completion of both AR-based and conventional examinations)). 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 9 Jul 2026.