Vestibular HypofunctionNCT07606196
The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases
A study testing Cawthorne-Cooksey Exercises, 2D Visual Habituation and 3D/Virtual Reality Visual Habituation in people with Vestibular Hypofunction and Vestibular Assessment, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study compared the clinical and electrophysiological effectiveness of three vestibular rehabilitation approaches in patients with unilateral peripheral vestibular disease accompanied by otolith dysfunction: (1) traditional Cawthorne-Cooksey exercises (CCE), (2) two-dimensional (2D)… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vestibular Hypofunction, Vestibular Assessment, Vestibular Exercises
- What is being tested?
- Cawthorne-Cooksey Exercises, 2D Visual Habituation and 3D/Virtual Reality Visual Habituation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 24 Mar 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed unilateral peripheral vestibular disease No identified hearing loss (symmetric hearing) VEMP interaural asymmetry >40% At least 3 months post-acute attack (chronic phase) No ocular disorders No cervical/physical problems No history of psychological or neurological disorders No regular use of alcohol or vestibular suppressant medications Non-fluctuating vestibular symptoms
Who cannot join
- Additional balance disorder pathology beyond unilateral peripheral vestibular disease BPPV repositioning maneuver within the last 30 days Asymmetric or moderate-to-severe hearing loss Motion sickness Active BPPV symptoms in history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Istanbul, 34810
About this study
Official title: The Effect and Rehabilitation of Otolith Dysfunction in Vestibular Diseases: A Randomized Comparison of Cawthorne-Cooksey Exercises, 2D Visual Habituation, and 3D/Virtual Reality Visual Habituation
This randomized controlled study compared the clinical and electrophysiological effectiveness of three vestibular rehabilitation approaches in patients with unilateral peripheral vestibular disease accompanied by otolith dysfunction: (1) traditional Cawthorne-Cooksey exercises (CCE), (2) two-dimensional (2D) otolith-targeted visual habituation, and (3) three-dimensional/virtual reality (3D/VR) otolith-targeted visual habituation. Forty-five patients aged 18-60 years were randomized into three groups and followed for 6 weeks. The Dizziness Handicap Inventory (DHI) was used as the primary clinical outcome, and cervical and ocular Vestibular Evoked Myogenic Potentials (cVEMP and oVEMP) were used as objective electrophysiological measures. Patients were monitored remotely using the Moodle learning management system.
Read the detailed description
Vestibular rehabilitation is a cornerstone of management in peripheral vestibular hypofunction. While conventional protocols such as the Cawthorne-Cooksey exercises focus largely on vestibulo-ocular reflex adaptation, otolith organs (utricle and saccule) are often underaddressed despite their critical role in spatial orientation and postural stability. Visual habituation protocols delivering wide-field optokinetic stimuli in the horizontal and vertical planes may target otolith-related symptoms more directly.
In this trial, 45 patients with chronic unilateral peripheral vestibular hypofunction (>3 months post-attack) and VEMP asymmetry >40% were randomized into three groups: CCE (n=16), 2D visual habituation (n=13), and 3D/VR visual habituation (n=16). Each group performed assigned exercises three times daily for 6 weeks, supported by the Moodle e-learning platform. Outcomes were assessed pre- and post-intervention using DHI and cVEMP/oVEMP latency, amplitude, and interaural asymmetry ratio (IAR).
- Conditions
- Vestibular Hypofunction, Vestibular Assessment, Vestibular Exercises, Vestibulopathy, Rehabilitation, Unilateral Vestibular Deficit
- Being tested
- Cawthorne-Cooksey Exercises, 2D Visual Habituation, 3D/Virtual Reality Visual Habituation
- Keywords
- Otolith dysfunction, Vestibular rehabilitation, Virtual reality, Visual habituation, VEMP, cVEMP, oVEMP, Dizziness Handicap Inventory, Cawthorne-Cooksey exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cawthorne-Cooksey ExercisesBehavioural
A classical vestibular rehabilitation protocol promoting central vestibular compensation through habituation and adaptation mechanisms. The 6-week protocol consists of hierarchical eye, head, and body movements progressing across three phases: Weeks 1-2 in sitting position (saccade and VOR exercises, single-leg standing, head shaking with eyes closed); Weeks 3-4 in standing position (saccades and VOR while standing, walking on mat, sit-to-stand exercises); Weeks 5-6 dynamic phase (saccades and VOR while walking, walking with head shaking, single-leg standing on soft surface). Exercises were performed three times daily (morning, noon, evening). Progression was individualized based on symptom provocation. Patients received initial in-clinic training and were followed remotely via the Moodle e-learning platform with weekly video-based exercise modules.
2D Visual HabituationBehavioural
A digital visual habituation protocol targeting otolith organs through wide-field 2D optokinetic visual flow stimuli. Pre-recorded videos generating horizontal-plane and vertical-plane motion perception (vection) were used to promote otolith re-weighting and habituation. Participants viewed videos seated in front of a screen at eye level, 1 meter away. Each session lasted 15-20 minutes and was performed three times daily (morning, noon, evening) for 6 weeks. Both horizontal and vertical optokinetic stimuli were delivered per session. Stimulus duration, speed, and complexity were gradually increased according to individual symptom tolerance. Sessions were paused if marked nausea or severe dizziness developed. Patients accessed videos through dedicated Moodle e-learning platform modules via smartphone or computer, ensuring standardized delivery and adherence monitoring.
3D/Virtual Reality Visual HabituationDevice
An immersive virtual reality (VR) visual habituation protocol targeting otolith organs through 3D wide-field optokinetic stimuli. The horizontal- and vertical-plane motion stimuli used in the 2D protocol were adapted for VR delivery using Movavi Video Editor 360 software and presented via a head-mounted display (VR Shinecon G04ea, Scinecon, China). Participants were immersed in 3D visual flow scenarios generating motion perception (vection), providing a more naturalistic stimulus than screen-based delivery. Sessions lasted 15-20 minutes and were performed three times daily for 6 weeks. Stimulus intensity and complexity were progressively increased according to tolerance. Short breaks were provided to minimize cybersickness. The Moodle platform supported protocol delivery and remote adherence monitoring. The protocol targeted otolith-related symptoms through systematic desensitization and sensory re-weighting.
| Study group | Role | What they receive |
|---|---|---|
| Cawthorne-Cooksey Exercises (CCE) | Active comparator | Traditional vestibular rehabilitation protocol consisting of progressive eye, head, and body movements (saccade and VOR exercises, balance exercises) performed three times daily for 6 weeks, with hierarchical difficulty progression across weeks 1-2, 3-4, and 5-6. Receives: Behavioral: Cawthorne-Cooksey Exercises |
| 2D Visual Habituation | Experimental | Otolith-targeted visual habituation using 2D wide-field optokinetic flow videos in horizontal and vertical planes. Patients viewed videos on a screen positioned at eye level at 1 meter distance, three times daily (morning/noon/evening), approximately 15-20 minutes per session, for 6 weeks. Receives: Behavioral: 2D Visual Habituation |
| 3D/Virtual Reality Visual Habituation | Experimental | Otolith-targeted visual habituation delivered via VR headset (VR Shinecon G04ea) presenting 3D wide-field optokinetic flow in horizontal and vertical planes. Same dosing as 2D arm: three times daily, 15-20 minutes per session, for 6 weeks. Receives: Device: 3D/Virtual Reality Visual Habituation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Dizziness Handicap Inventory (DHI) total score
The Dizziness Handicap Inventory (DHI) is a 25-item self-report questionnaire measuring perceived dizziness-related handicap. Each item is scored as "Yes" (4 points), "Sometimes" (2 points), or "No" (0 points). The total score is calculated by summing all 25 items and ranges from 0 to 100, where 0 indicates no perceived handicap and 100 indicates maximum perceived handicap. Higher scores represent greater dizziness-related disability. The outcome is reported as the mean change in total DHI score, calculated as post-intervention total score minus baseline total score for each participant.
Measured: Baseline and 6 weeks post-intervention
Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) P13 wave latency
Cervical Vestibular Evoked Myogenic Potential (cVEMP) P13 wave latency is an objective electrophysiological measure of saccular and inferior vestibular nerve function. Recordings were obtained using the Interacoustics Eclipse platform with 500 Hz tone-burst stimuli at 100 dB SPL delivered monaurally through insert earphones. Surface EMG electrodes were placed over the sternocleidomastoid muscle, with the ground electrode at the vertex and reference electrode at the sternum. The latency of the first positive peak (P13) was measured from stimulus onset to peak in milliseconds. The outcome is reported as the mean change in P13 latency, calculated as post-intervention latency minus baseline latency for each participant.
Measured: Baseline and 6 weeks post-intervention
Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) N23 wave latency
Cervical Vestibular Evoked Myogenic Potential (cVEMP) N23 wave latency is an objective electrophysiological measure of saccular and inferior vestibular nerve function. Recordings were obtained using the Interacoustics Eclipse platform with 500 Hz tone-burst stimuli at 100 dB SPL delivered monaurally through insert earphones. Surface EMG electrodes were placed over the sternocleidomastoid muscle. The latency of the negative peak (N23) following the P13 peak was measured from stimulus onset to peak in milliseconds. The outcome is reported as the mean change in N23 latency, calculated as post-intervention latency minus baseline latency for each participant.
Measured: Baseline and 6 weeks post-intervention
Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) N10 wave latency
Ocular Vestibular Evoked Myogenic Potential (oVEMP) N10 wave latency is an objective electrophysiological measure of utricular and superior vestibular nerve function. Recordings were obtained using the Interacoustics Eclipse platform with monaural acoustic stimuli delivered through insert earphones. Surface electrodes were placed below the contralateral eye over the inferior oblique muscle, with reference electrodes 2 cm below the active electrodes and ground at the vertex. Participants maintained an upward gaze at a fixed visual target during recording. The latency of the first negative peak (N10) was measured from stimulus onset to peak in milliseconds. The outcome is reported as the mean change in N10 latency, calculated as post-intervention latency minus baseline latency for each participant.
Measured: Baseline and 6 weeks post-intervention
Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) P15 wave latency
Ocular Vestibular Evoked Myogenic Potential (oVEMP) P15 wave latency is an objective electrophysiological measure of utricular and superior vestibular nerve function. Recordings were obtained using the Interacoustics Eclipse platform with monaural acoustic stimuli delivered through insert earphones. Surface electrodes were placed over the inferior oblique muscle below the contralateral eye, with participants maintaining an upward gaze at a fixed visual target. The latency of the positive peak (P15) following the N10 peak was measured from stimulus onset to peak in milliseconds. The outcome is reported as the mean change in P15 latency, calculated as post-intervention latency minus baseline latency for each participant.
Measured: Baseline and 6 weeks post-intervention
Secondary outcomes (4)
Change in cVEMP peak-to-peak amplitude from baseline to 6 weeks
Measured: Baseline and 6 weeks post-intervention
Change in oVEMP peak-to-peak amplitude from baseline to 6 weeks
Measured: Baseline and 6 weeks post-intervention
Change in cVEMP interaural asymmetry ratio (IAR) from baseline to 6 weeks
Measured: Baseline and 6 weeks post-intervention
Change in oVEMP interaural asymmetry ratio (IAR) from baseline to 6 weeks
Measured: Baseline and 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Mar 2025
- Primary completion24 Dec 2025
- Study completion24 Mar 2026
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 Vestibular HypofunctionStudies of the same condition, open and under way.
- More trials run by Medipol 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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medeniyet University
- Responsible party
- Principal investigator, Şeyma Tuğba Öztürk, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606196
- Sponsor's protocol ID
- stozturk1
- Other IDs
- 1063 (21.12.2023)
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen PY, Hsieh WL, Wei SH, Kao CL. Interactive wiimote gaze stabilization exercise training system for patients with vestibular hypofunction. J Neuroeng Rehabil. 2012 Oct 9;9:77. doi: 10.1186/1743-0003-9-77.
PubMed 23043886Smolka W, Smolka K, Markowski J, Pilch J, Piotrowska-Seweryn A, Zwierzchowska A. The efficacy of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction. Int J Occup Med Environ Health. 2020 Apr 30;33(3):273-282. doi: 10.13075/ijomeh.1896.01330. Epub 2020 Mar 26.
PubMed 32235946Lacour M, Helmchen C, Vidal PP. Vestibular compensation: the neuro-otologist's best friend. J Neurol. 2016 Apr;263 Suppl 1:S54-64. doi: 10.1007/s00415-015-7903-4. Epub 2016 Apr 15.
PubMed 27083885Dutia MB. Mechanisms of vestibular compensation: recent advances. Curr Opin Otolaryngol Head Neck Surg. 2010 Oct;18(5):420-4. doi: 10.1097/MOO.0b013e32833de71f.
PubMed 20693901Fujimoto C, Suzuki S, Kinoshita M, Egami N, Sugasawa K, Iwasaki S. Clinical features of otolith organ-specific vestibular dysfunction. Clin Neurophysiol. 2018 Jan;129(1):238-245. doi: 10.1016/j.clinph.2017.11.006. Epub 2017 Nov 21.
PubMed 29207275Baloh RW, Kerber KA. Clinical Neurophysiology of the Vestibular System. p.480, 4th ed. Oxford: Oxford University Press, 2010
Van De Graaff KM. Senses of hearing and balance. p.516-30. In: Human Anatomy. 6th ed. The McGraw-Hill Companies Publishing, 2001
Dickman JD. The vestibular system. p.320-333 In: Fundamental Neuroscience for Basic and Clinical Applications. 5th ed. Elsevier Inc, 2018.
Öndağ N. Periferik vestibüler sistem hastalıklarında uyarılmış vestibüler myojenik potansiyeller (VEMP). Gazi Üniversitesi, 2008.
Öztürk ŞT. The Effect and Rehabilitation of Otolith Dysfunction in Vestibular Diseases [doctoral thesis]. Istanbul: Istanbul Medipol University; 2026.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Rehabilitation of Otolith Dysfunction in Vestibular Diseases: A Randomized Comparison of Cawthorne-Cooksey Exercises, 2D Visual Habituation, and 3D/Virtual Reality Visual Habituation
- ClinicalTrials.gov ID
- NCT07606196
- Acronym / sponsor ID
- stozturk1
- Conditions
- Vestibular Hypofunction, Vestibular Assessment, Vestibular Exercises, Vestibulopathy, Rehabilitation, Unilateral Vestibular Deficit
- Keywords
- Otolith dysfunction, Vestibular rehabilitation, Virtual reality, Visual habituation, VEMP, cVEMP, oVEMP, Dizziness Handicap Inventory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- Istanbul Medeniyet University
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 26 May 2026 (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.
This randomized controlled study compared the clinical and electrophysiological effectiveness of three vestibular rehabilitation approaches in patients with unilateral peripheral vestibular disease accompanied by otolith dysfunction: (1) traditional Cawthorne-Cooksey exercises (CCE), (2) two-dimensional (2D) otolith-targeted visual habituation, and (3) three-dimensional/virtual reality (3D/VR) otolith-targeted visual habituation. Forty-five patients aged 18-60 years were randomized into three groups and followed for 6 weeks. The Dizziness Handicap Inventory (DHI) was used as the primary clinical outcome, and cervical and ocular Vestibular Evoked Myogenic Potentials (cVEMP and oVEMP) were used as objective electrophysiological measures. Patients were monitored remotely using the Moodle learning management system.
Detailed description
Vestibular rehabilitation is a cornerstone of management in peripheral vestibular hypofunction. While conventional protocols such as the Cawthorne-Cooksey exercises focus largely on vestibulo-ocular reflex adaptation, otolith organs (utricle and saccule) are often underaddressed despite their critical role in spatial orientation and postural stability. Visual habituation protocols delivering wide-field optokinetic stimuli in the horizontal and vertical planes may target otolith-related symptoms more directly.
In this trial, 45 patients with chronic unilateral peripheral vestibular hypofunction (>3 months post-attack) and VEMP asymmetry >40% were randomized into three groups: CCE (n=16), 2D visual habituation (n=13), and 3D/VR visual habituation (n=16). Each group performed assigned exercises three times daily for 6 weeks, supported by the Moodle e-learning platform. Outcomes were assessed pre- and post-intervention using DHI and cVEMP/oVEMP latency, amplitude, and interaural asymmetry ratio (IAR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cawthorne-Cooksey Exercises (CCE) | Active comparator | Behavioral: Cawthorne-Cooksey ExercisesTraditional vestibular rehabilitation protocol consisting of progressive eye, head, and body movements (saccade and VOR exercises, balance exercises) performed three times daily for 6 weeks, with hierarchical difficulty progression across weeks 1-2, 3-4, and 5-6. |
| 2D Visual Habituation | Experimental | Behavioral: 2D Visual HabituationOtolith-targeted visual habituation using 2D wide-field optokinetic flow videos in horizontal and vertical planes. Patients viewed videos on a screen positioned at eye level at 1 meter distance, three times daily (morning/noon/evening), approximately 15-20 minutes per session, for 6 weeks. |
| 3D/Virtual Reality Visual Habituation | Experimental | Device: 3D/Virtual Reality Visual HabituationOtolith-targeted visual habituation delivered via VR headset (VR Shinecon G04ea) presenting 3D wide-field optokinetic flow in horizontal and vertical planes. Same dosing as 2D arm: three times daily, 15-20 minutes per session, for 6 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosed unilateral peripheral vestibular disease No identified hearing loss (symmetric hearing) VEMP interaural asymmetry >40% At least 3 months post-acute attack (chronic phase) No ocular disorders No cervical/physical problems No history of psychological or neurological disorders No regular use of alcohol or vestibular suppressant medications Non-fluctuating vestibular symptoms
Key exclusion criteria (1 listed)
- Additional balance disorder pathology beyond unilateral peripheral vestibular disease BPPV repositioning maneuver within the last 30 days Asymmetric or moderate-to-severe hearing loss Motion sickness Active BPPV symptoms in history
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 |
|---|---|---|
| Cawthorne-Cooksey ExercisesA classical vestibular rehabilitation protocol promoting central vestibular compensation through habituation and adaptation mechanisms. The 6-week protocol consists of hierarchical eye, head, and body movements progressing across three phases: Weeks 1-2 in sitting position (saccade and VOR exercises, single-leg standing, head shaking with eyes closed); Weeks 3-4 in standing position (saccades and VOR while standing, walking on mat, sit-to-stand exercises); Weeks 5-6 dynamic phase (saccades and VOR while walking, walking with head shaking, single-leg standing on soft surface). Exercises were performed three times daily (morning, noon, evening). Progression was individualized based on symptom provocation. Patients received initial in-clinic training and were followed remotely via the Moodle e-learning platform with weekly video-based exercise modules. | Behavioural | Cawthorne-Cooksey Exercises (CCE) |
| 2D Visual HabituationA digital visual habituation protocol targeting otolith organs through wide-field 2D optokinetic visual flow stimuli. Pre-recorded videos generating horizontal-plane and vertical-plane motion perception (vection) were used to promote otolith re-weighting and habituation. Participants viewed videos seated in front of a screen at eye level, 1 meter away. Each session lasted 15-20 minutes and was performed three times daily (morning, noon, evening) for 6 weeks. Both horizontal and vertical optokinetic stimuli were delivered per session. Stimulus duration, speed, and complexity were gradually increased according to individual symptom tolerance. Sessions were paused if marked nausea or severe dizziness developed. Patients accessed videos through dedicated Moodle e-learning platform modules via smartphone or computer, ensuring standardized delivery and adherence monitoring. | Behavioural | 2D Visual Habituation |
| 3D/Virtual Reality Visual HabituationAn immersive virtual reality (VR) visual habituation protocol targeting otolith organs through 3D wide-field optokinetic stimuli. The horizontal- and vertical-plane motion stimuli used in the 2D protocol were adapted for VR delivery using Movavi Video Editor 360 software and presented via a head-mounted display (VR Shinecon G04ea, Scinecon, China). Participants were immersed in 3D visual flow scenarios generating motion perception (vection), providing a more naturalistic stimulus than screen-based delivery. Sessions lasted 15-20 minutes and were performed three times daily for 6 weeks. Stimulus intensity and complexity were progressively increased according to tolerance. Short breaks were provided to minimize cybersickness. The Moodle platform supported protocol delivery and remote adherence monitoring. The protocol targeted otolith-related symptoms through systematic desensitization and sensory re-weighting. | Device | 3D/Virtual Reality Visual Habituation |
Primary outcome
Mean change in Dizziness Handicap Inventory (DHI) total score
Time frame: Baseline and 6 weeks post-intervention
The Dizziness Handicap Inventory (DHI) is a 25-item self-report questionnaire measuring perceived dizziness-related handicap. Each item is scored as "Yes" (4 points), "Sometimes" (2 points), or "No" (0 points). The total score is calculated by summing all 25 items and ranges from 0 to 100, where 0 indicates no perceived handicap and 100 indicates maximum perceived handicap. Higher scores represent greater dizziness-related disability. The outcome is reported as the mean change in total DHI score, calculated as post-intervention total score minus baseline total score for each participant.
Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) P13 wave latency
Time frame: Baseline and 6 weeks post-intervention
Cervical Vestibular Evoked Myogenic Potential (cVEMP) P13 wave latency is an objective electrophysiological measure of saccular and inferior vestibular nerve function. Recordings were obtained using the Interacoustics Eclipse platform with 500 Hz tone-burst stimuli at 100 dB SPL delivered monaurally through insert earphones. Surface EMG electrodes were placed over the sternocleidomastoid muscle, with the ground electrode at the vertex and reference electrode at the sternum. The latency of the first positive peak (P13) was measured from stimulus onset to peak in milliseconds. The outcome is reported as the mean change in P13 latency, calculated as post-intervention latency minus baseline latency for each participant.
Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) N23 wave latency
Time frame: Baseline and 6 weeks post-intervention
Cervical Vestibular Evoked Myogenic Potential (cVEMP) N23 wave latency is an objective electrophysiological measure of saccular and inferior vestibular nerve function. Recordings were obtained using the Interacoustics Eclipse platform with 500 Hz tone-burst stimuli at 100 dB SPL delivered monaurally through insert earphones. Surface EMG electrodes were placed over the sternocleidomastoid muscle. The latency of the negative peak (N23) following the P13 peak was measured from stimulus onset to peak in milliseconds. The outcome is reported as the mean change in N23 latency, calculated as post-intervention latency minus baseline latency for each participant.
Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) N10 wave latency
Time frame: Baseline and 6 weeks post-intervention
Ocular Vestibular Evoked Myogenic Potential (oVEMP) N10 wave latency is an objective electrophysiological measure of utricular and superior vestibular nerve function. Recordings were obtained using the Interacoustics Eclipse platform with monaural acoustic stimuli delivered through insert earphones. Surface electrodes were placed below the contralateral eye over the inferior oblique muscle, with reference electrodes 2 cm below the active electrodes and ground at the vertex. Participants maintained an upward gaze at a fixed visual target during recording. The latency of the first negative peak (N10) was measured from stimulus onset to peak in milliseconds. The outcome is reported as the mean change in N10 latency, calculated as post-intervention latency minus baseline latency for each participant.
Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) P15 wave latency
Time frame: Baseline and 6 weeks post-intervention
Ocular Vestibular Evoked Myogenic Potential (oVEMP) P15 wave latency is an objective electrophysiological measure of utricular and superior vestibular nerve function. Recordings were obtained using the Interacoustics Eclipse platform with monaural acoustic stimuli delivered through insert earphones. Surface electrodes were placed over the inferior oblique muscle below the contralateral eye, with participants maintaining an upward gaze at a fixed visual target. The latency of the positive peak (P15) following the N10 peak was measured from stimulus onset to peak in milliseconds. The outcome is reported as the mean change in P15 latency, calculated as post-intervention latency minus baseline latency for each participant.
4 secondary outcomes
Change in cVEMP peak-to-peak amplitude from baseline to 6 weeks
Time frame: Baseline and 6 weeks post-intervention
Change in oVEMP peak-to-peak amplitude from baseline to 6 weeks
Time frame: Baseline and 6 weeks post-intervention
Change in cVEMP interaural asymmetry ratio (IAR) from baseline to 6 weeks
Time frame: Baseline and 6 weeks post-intervention
Change in oVEMP interaural asymmetry ratio (IAR) from baseline to 6 weeks
Time frame: Baseline and 6 weeks post-intervention
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 26 May 2026.
- Background: PubMed 23043886Chen PY, Hsieh WL, Wei SH, Kao CL. Interactive wiimote gaze stabilization exercise training system for patients with vestibular hypofunction. J Neuroeng Rehabil. 2012 Oct 9;9:77. doi: 10.1186/1743-0003-9-77.
- Background: PubMed 32235946Smolka W, Smolka K, Markowski J, Pilch J, Piotrowska-Seweryn A, Zwierzchowska A. The efficacy of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction. Int J Occup Med Environ Health. 2020 Apr 30;33(3):273-282. doi: 10.13075/ijomeh.1896.01330. Epub 2020 Mar 26.
- Background: PubMed 27083885Lacour M, Helmchen C, Vidal PP. Vestibular compensation: the neuro-otologist's best friend. J Neurol. 2016 Apr;263 Suppl 1:S54-64. doi: 10.1007/s00415-015-7903-4. Epub 2016 Apr 15.
- Background: PubMed 20693901Dutia MB. Mechanisms of vestibular compensation: recent advances. Curr Opin Otolaryngol Head Neck Surg. 2010 Oct;18(5):420-4. doi: 10.1097/MOO.0b013e32833de71f.
- Background: PubMed 29207275Fujimoto C, Suzuki S, Kinoshita M, Egami N, Sugasawa K, Iwasaki S. Clinical features of otolith organ-specific vestibular dysfunction. Clin Neurophysiol. 2018 Jan;129(1):238-245. doi: 10.1016/j.clinph.2017.11.006. Epub 2017 Nov 21.
- BackgroundBaloh RW, Kerber KA. Clinical Neurophysiology of the Vestibular System. p.480, 4th ed. Oxford: Oxford University Press, 2010
- BackgroundVan De Graaff KM. Senses of hearing and balance. p.516-30. In: Human Anatomy. 6th ed. The McGraw-Hill Companies Publishing, 2001
- BackgroundDickman JD. The vestibular system. p.320-333 In: Fundamental Neuroscience for Basic and Clinical Applications. 5th ed. Elsevier Inc, 2018.
- BackgroundÖndağ N. Periferik vestibüler sistem hastalıklarında uyarılmış vestibüler myojenik potansiyeller (VEMP). Gazi Üniversitesi, 2008.
- Results publicationÖztürk ŞT. The Effect and Rehabilitation of Otolith Dysfunction in Vestibular Diseases [doctoral thesis]. Istanbul: Istanbul Medipol University; 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cawthorne-Cooksey Exercises, 2D Visual Habituation and 3D/Virtual Reality Visual Habituation in people with Vestibular Hypofunction and Vestibular Assessment, run by Medipol 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 1 inclusion and 1 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 26 May 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 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?
Mean change in Dizziness Handicap Inventory (DHI) total score (time frame: Baseline and 6 weeks post-intervention). The study lists 5 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 NCT07606196, 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 26 May 2026.