Vestibular DisorderSWANNCT05622344
StableEyes With Active Neurofeedback
A study testing Traditional Therapy and SWAN in people with Vestibular Disorder and Vestibular Schwannoma, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The investigators have developed a self-administered rehabilitation tool that incrementally guides the user to increase head motion to mitigate motion sickness and enhance postural recovery following centrifugation or unilateral vestibular nerve deafferentation surgery. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder, Vestibular Schwannoma, Space Motion Sickness
- What is being tested?
- Traditional Therapy and SWAN
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2022to 30 Mar 2027
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- In good general health as evidenced by medical history or diagnosed with unilateral vestibular schwannoma
- Willing to adhere to the SWAN and/or vestibular rehabilitation regimen
Who cannot join
- Current use of anti-nausea medication
- Presence of cervical spine pathology that limits head motion to < 30 degrees in the horizontal or vertical plane (i.e. degenerative disc disease, rheumatoid arthritis)
- Any orthopedic pathology that prevents walking or standing independently (i.e. recent surgery)
- Legal blindness (20/200 or worse visual acuity)
- Treatment using a motion sickness investigational drug or other motion sickness behavioral intervention within 30 days
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Michael C Schubert, PhD, 410-955-3403, mschube1@jhmi.edu
Colin R Grove, PhD
- Enrolling by invitation
Naval Medical Research Unit
Dayton, Ohio, 45433
About this study
Official title: StableEyes With Active Neurophysiological Feedback
The investigators have developed a self-administered rehabilitation tool that incrementally guides the user to increase head motion to mitigate motion sickness and enhance postural recovery following centrifugation or unilateral vestibular nerve deafferentation surgery.
Read the detailed description
The rehabilitation device guides users to perform sinusoidal head rotations, matched to a metronome, about the yaw, pitch, and roll axes (60 sec epochs, 5 minutes per axis, 15 min total). The assessment for each axis consists of the number of completed epochs with each epoch requiring head rotations of a different amplitude. Subjects are instructed to begin with an 'easy' amplitude (i.e. small) and increase or decrease amplitude depending on the subject's perception of motion sickness - which is input from 0 (absent motion sick) to 11 (vomit) using a handheld controller. Video-oculography captures eye and head velocity as well as tracks the number of blinks and saccades, metrics that can indicate worsening nausea.
- Being tested
- Traditional Therapy, SWAN
- Medical subject headings
- Vestibular Diseases, Neuroma, Acoustic, Space Motion Sickness, Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional TherapyBehavioural
Also called Gaze stability exercises
Exercises that teaches subjects to move their heads while viewing still or moving targets.
SWANDevice
Also called StableEyes Training Device with video-oculography
The SWAN device uses video-oculography to monitor head motion while guiding participants to move their head in yaw, pitch, roll planes for 15 minutes. Feedback is provided regarding frequency and plane of head rotation
| Study group | Role | What they receive |
|---|---|---|
| Traditional Vestibular Physical Therapy (VPT) JHU | Active comparator | Subjects that have had their eighth cranial nerve resected will receive traditional vestibular rehabilitation exercises at Johns Hopkins University (JHU) site. Receives: Behavioral: Traditional Therapy |
| SWAN VPT JHU | Experimental | Subjects that have had their eighth cranial nerve resected will receive the automated vestibular rehabilitation method Receives: Device: SWAN |
| SWAN Motion Sick Dayton | Experimental | Healthy control subjects that meet similar similar physical characteristics of astronauts will receive the automated vestibular rehabilitation method post motion sickness. Receives: Device: SWAN |
| Traditional Motion Sick Dayton | No intervention | Typically, the suggestion for treating motion sickness once it has started is to avoid motion. Therefore, healthy control subjects that meet similar similar physical characteristics of astronauts will not receive any post motion sickness treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Motion sickness intensity as assessed by subjective rating
Subjective rating of motion sickness intensity from 0 to 10. Zero denotes absent motion sickness while 10 denote vomiting.
Measured: Daily for up to 4 weeks
Secondary outcomes (15)
Change in Vestibulo-Ocular Reflex (VOR) gain as measured by video-oculography
Ratio of eye velocity to head velocity that varies from 0 to 1.2. Normal scores are greater than 0.8.
Measured: Daily for up to 4 weeks
Change in Number of blinks as measured by video-oculography
Increase blinking is correlated with worse motion sickness.
Measured: Daily for up to 4 weeks
Change in Heart rate as measured by a monitor worn over the forearm
Heart rate in beats per minute will be measured using a monitor worn over the forearm.
Measured: Daily for up to 4 weeks
Change in Timed Up and Go Plus
Time measured in seconds for a subject to stand up, step over an obstacle then walk 3M before turning around and sitting down.
Measured: Daily for up to 4 weeks
Change in Foam Stance - Eyes Open
Time in seconds to stand on foam with eyes open. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling.
Measured: Daily for up to 4 weeks
Change in Foam Stance - Eyes Closed
Time in seconds to stand on foam with eyes closed. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling.
Measured: Daily for up to 4 weeks
Change in Foam Stance - Eyes Open with head motion
Time to seconds to stand on foam with eyes open while moving head up and down. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling.
Measured: Daily for up to 4 weeks
Change in Foam Stance - Eyes Closed with head motion
Time in seconds to stand on foam with eyes closed while moving head up and down. Inability to stand for less than 20 seconds is associated with 3x greater risk for falling.
Measured: Daily for up to 4 weeks
Change in Gait speed
Velocity to walk 6m within a 10m marked distance, measured in meters/second. Normative data exists based on decade of age.
Measured: Daily for up to 4 weeks
Change in Gait endurance
Distance walked in 2 minutes, measure in meters.
Measured: Daily for up to 4 weeks
Change in Vertical and torsional alignment nulling test (VAN and TAN)
Vertical alignment nulling and torsional alignment nulling ask subjects to adjust lines to there perceived horizontal. Measured in degrees.
Measured: Daily for up to 4 weeks
Change in Rod and Frame Test
Subjects adjust a virtual line to their perceived vertical, measured in degrees.
Measured: Daily for up to 4 weeks
Change in Rod and Disk Test
Subjects adjust a virtual line to their perceived vertical, measured in degrees.
Measured: Daily for up to 4 weeks
Change in Subjective Visual Vertical
Subjects adjust a virtual line to their perceived vertical, measured in degrees.
Measured: Daily for up to 4 weeks
Change in Daily Activity as assessed by an activity monitor
Subjects wear an activity monitor on their wrist Data includes daily distance walked .
Measured: Daily for up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start8 Aug 2022
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Model description
- At each site, one group will receive the control and the second group will receive the experimental treatment (novel rehab device).
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Responsible party
- Sponsor
- Investigators
- Matthew Stewart, MD PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622344
- Sponsor's protocol ID
- IRB00281972
- Other IDs
- 80NSSC21M0057
- Acronym
- SWAN
- Status last verified
- Sep 2026
- First submitted
- 11 Nov 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, we have no plan to share data with other researchers
Publications
Todd CJ, Schubert MC, Rinaudo CN, Migliaccio AA. Unidirectional Vertical Vestibuloocular Reflex Adaptation in Humans Using 1D and 2D Scenes. Otol Neurotol. 2022 Oct 1;43(9):e1039-e1044. doi: 10.1097/MAO.0000000000003684. Epub 2022 Sep 9.
PubMed 36075099
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StableEyes With Active Neurophysiological Feedback
- ClinicalTrials.gov ID
- NCT05622344
- Acronym / sponsor ID
- SWAN / IRB00281972
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 18 Nov 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.
The investigators have developed a self-administered rehabilitation tool that incrementally guides the user to increase head motion to mitigate motion sickness and enhance postural recovery following centrifugation or unilateral vestibular nerve deafferentation surgery.
Detailed description
The rehabilitation device guides users to perform sinusoidal head rotations, matched to a metronome, about the yaw, pitch, and roll axes (60 sec epochs, 5 minutes per axis, 15 min total). The assessment for each axis consists of the number of completed epochs with each epoch requiring head rotations of a different amplitude. Subjects are instructed to begin with an 'easy' amplitude (i.e. small) and increase or decrease amplitude depending on the subject's perception of motion sickness - which is input from 0 (absent motion sick) to 11 (vomit) using a handheld controller. Video-oculography captures eye and head velocity as well as tracks the number of blinks and saccades, metrics that can indicate worsening nausea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- At each site, one group will receive the control and the second group will receive the experimental treatment (novel rehab device).
| Arm | Type | Receives |
|---|---|---|
| Traditional Vestibular Physical Therapy (VPT) JHU | Active comparator | Behavioral: Traditional TherapySubjects that have had their eighth cranial nerve resected will receive traditional vestibular rehabilitation exercises at Johns Hopkins University (JHU) site. |
| SWAN VPT JHU | Experimental | Device: SWANSubjects that have had their eighth cranial nerve resected will receive the automated vestibular rehabilitation method |
| SWAN Motion Sick Dayton | Experimental | Device: SWANHealthy control subjects that meet similar similar physical characteristics of astronauts will receive the automated vestibular rehabilitation method post motion sickness. |
| Traditional Motion Sick Dayton | No intervention | –Typically, the suggestion for treating motion sickness once it has started is to avoid motion. Therefore, healthy control subjects that meet similar similar physical characteristics of astronauts will not receive any post motion sickness treatment. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- In good general health as evidenced by medical history or diagnosed with unilateral vestibular schwannoma
- Willing to adhere to the SWAN and/or vestibular rehabilitation regimen
Key exclusion criteria (5 listed)
- Current use of anti-nausea medication
- Presence of cervical spine pathology that limits head motion to < 30 degrees in the horizontal or vertical plane (i.e. degenerative disc disease, rheumatoid arthritis)
- Any orthopedic pathology that prevents walking or standing independently (i.e. recent surgery)
- Legal blindness (20/200 or worse visual acuity)
- Treatment using a motion sickness investigational drug or other motion sickness behavioral intervention within 30 days
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 TherapyAlso: Gaze stability exercisesExercises that teaches subjects to move their heads while viewing still or moving targets. | Behavioural | Traditional Vestibular Physical Therapy (VPT) JHU |
| SWANAlso: StableEyes Training Device with video-oculographyThe SWAN device uses video-oculography to monitor head motion while guiding participants to move their head in yaw, pitch, roll planes for 15 minutes. Feedback is provided regarding frequency and plane of head rotation | Device | SWAN Motion Sick Dayton, SWAN VPT JHU |
Primary outcome
Change in Motion sickness intensity as assessed by subjective rating
Time frame: Daily for up to 4 weeks
Subjective rating of motion sickness intensity from 0 to 10. Zero denotes absent motion sickness while 10 denote vomiting.
15 secondary outcomes
Change in Vestibulo-Ocular Reflex (VOR) gain as measured by video-oculography
Time frame: Daily for up to 4 weeks
Change in Number of blinks as measured by video-oculography
Time frame: Daily for up to 4 weeks
Change in Heart rate as measured by a monitor worn over the forearm
Time frame: Daily for up to 4 weeks
Change in Timed Up and Go Plus
Time frame: Daily for up to 4 weeks
Change in Foam Stance - Eyes Open
Time frame: Daily for up to 4 weeks
Change in Foam Stance - Eyes Closed
Time frame: Daily for up to 4 weeks
Change in Foam Stance - Eyes Open with head motion
Time frame: Daily for up to 4 weeks
Change in Foam Stance - Eyes Closed with head motion
Time frame: Daily for up to 4 weeks
Change in Gait speed
Time frame: Daily for up to 4 weeks
Change in Gait endurance
Time frame: Daily for up to 4 weeks
Change in Vertical and torsional alignment nulling test (VAN and TAN)
Time frame: Daily for up to 4 weeks
Change in Rod and Frame Test
Time frame: Daily for up to 4 weeks
Change in Rod and Disk Test
Time frame: Daily for up to 4 weeks
Change in Subjective Visual Vertical
Time frame: Daily for up to 4 weeks
Change in Daily Activity as assessed by an activity monitor
Time frame: Daily for up to 4 weeks
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 8 Sep 2026.
- Background: PubMed 36075099Todd CJ, Schubert MC, Rinaudo CN, Migliaccio AA. Unidirectional Vertical Vestibuloocular Reflex Adaptation in Humans Using 1D and 2D Scenes. Otol Neurotol. 2022 Oct 1;43(9):e1039-e1044. doi: 10.1097/MAO.0000000000003684. Epub 2022 Sep 9.
- Patent for the rehabilitation deviceLink provided by the sponsor.
- Patent for the integrated video-oculography and rehabilitation deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No. Currently, we have no plan to share data with other researchers
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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.
Matthew Stewart, MD PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Therapy and SWAN in people with Vestibular Disorder and Vestibular Schwannoma, run by Johns Hopkins University at 2 sites in United States.
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 4 inclusion and 5 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Michael Schubert, PhD (4108427403, mschube1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motion sickness intensity as assessed by subjective rating (time frame: Daily for up to 4 weeks). 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 NCT05622344, which also lists 1 linked publication.
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 8 Sep 2026.