AnxietyNCT04999709

Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety

A study testing VeNS in people with Anxiety, run by Neurovalens Ltd. at 1 site in Hong Kong.

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 18 to 80 years
Conditions the study is for: Anxiety
What is being tested?: VeNS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 1 siteHong Kong
Study dates: 11 Jul 2022to 25 May 2023
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent
Male or female, age ≥ 18 years and ≤ 80 years at the time of signing informed consent.
Report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7)
Ability and willingness to complete all study visits and procedures
Agreement to engage with using the device on a daily basis
Agreement to engage with trial mentors

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Agreement not to use prescription, or over the counter, anxiety medications for the duration of the trial
Access to Wi-Fi
Access to Apple smart phone (If not an Apple iPod will be supplied)

Who cannot join

History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working)
Use of beta-blockers within 1 month of starting the study
Use of antidepressants or unstable dose within 3 months of starting study
Medication for anxiety (unless regime stable for last 3 months).
A history of stroke or severe head injury (as defined by a head injury that required a craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation).

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Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
History of epilepsy
History of active migraines with aura
History of head injury requiring intensive care or neurosurgery
History of cognitive impairment
History of of bipolar, psychotic or substance use disorders
Regular use (more than twice a month) of antihistamine medication within the last 6 months.
History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
A diagnosis of myelofibrosis or a myelodysplastic syndrome.
Previous use of Modius device
Participation in other clinical trials sponsored by Neurovalens
Participation in any other anxiety studies
Have a member of the same household who is currently participating in this study.
Not fluent in English language
History of vestibular dysfunction or other inner ear disease as indicated by the following screening questions:
Do you have a history of any of the following?
Have you had hearing trouble?
Do you need hearing aids?
Have you had Ear Surgery resulting in hearing or balance loss?
Do you have Ear Pain?
Do you have tinnitus? (A ringing or buzzing in one or both ears)
Do you have dizziness?
Do you have trouble with balance?

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

School of Nursing, The Hong Kong Polytechnic University
Hung Hom, Kowloon

Other trials in Hong Kong

About this study

Official title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control For Treatment Of Anxiety.

Anxiety is known to be one of the most common health concerns in in the general population, and the most common mental health issue, and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for anxiety but comes with a risk of adverse effects. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of anxiety but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and anxiety continues to be explored, however its usefulness in the treatment of anxiety is still unknown. Vestibular stimulation itself has been shown to be safe across multiple populations. If vestibular stimulation is shown to be effective in the treatment of anxiety, it could serve as a safer alternative to medications. It could also require less cost, time, and training than CBT-1, providing a treatment option that is not only safe and effective, but broadly available to the general population. It also could present an alternative intervention for patients who are non-responsive or refuse medication. Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with anxiety.

Conditions: Anxiety
Being tested: VeNS
Medical subject headings: Anxiety Disorders

What participants receive

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

VeNSDevice
The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.

Study groups in NCT04999709
Study group	Role	What they receive
Active	Active comparator	The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. Receives: Device: VeNS
Sham	Sham comparator	The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. Receives: Device: VeNS

What is being measured

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

Generalised Anxiety Disorder (GAD-7) Scores
To evaluate the effect of the VeNS device, relative to control group on participants with anxiety (range 0-21) with higher score indicating more severe anxiety.
Measured: 4 weeks

Secondary outcomes (3)

Number of adverse events
To evaluate the safety of the VeSTAL device relative to control group, in terms of the occurrence of adverse events.
Measured: 4 weeks
Quality of life using SF-36 scores
To evaluate the effect of the VeNS device, relative to control group, on quality of life. SF-36 is a 36-item short form survey (range 0-100) with higher scores indicating a better quality of life.
Measured: 4 weeks
Insomnia Severity Index (ISI) score
To evaluate the effect of the VeNS device, relative to control group on participants with insomnia. ISI is a self-report rating scale assessing the severity of insomnia symptoms (range 0-28) with higher scores indicating a more severe insomnia.
Measured: 4 weeks

Timeline

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

11 Jul 202225 May 2023

First posted11 Aug 2021
Study start11 Jul 2022
Primary completion28 Feb 2023
Study completion25 May 2023

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 AnxietyStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04999709
Sponsor's protocol ID: UUAS001
Status last verified: Jan 2024
First submitted: 2 Aug 2021
Last updated: 16 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.

Publications

Cheung T, Lam JYT, Fong KH, Ho YS, Ho A, Cheng CP, Sittlington J, Xiang YT, Li TMH. The Effectiveness of Electrical Vestibular Stimulation (VeNS) on Symptoms of Anxiety: Study Protocol of a Randomized, Double-Blinded, Sham-Controlled Trial. Int J Environ Res Public Health. 2023 Feb 27;20(5):4218. doi: 10.3390/ijerph20054218.
PubMed 36901227

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?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control For Treatment Of Anxiety.
ClinicalTrials.gov ID: NCT04999709
Acronym / sponsor ID: UUAS001
Conditions: Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Neurovalens Ltd.Industry (pharma, biotech, devices)
Collaborators: Clinical Trial Mentors
Study start: 11 Jul 2022 (actual)
Primary completion: 28 Feb 2023 (actual)
Study completion: 25 May 2023 (actual)
First posted: 11 Aug 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active	Active comparator	Device: VeNSThe active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.
Sham	Sham comparator	Device: VeNSThe sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Signed informed consent
Male or female, age ≥ 18 years and ≤ 80 years at the time of signing informed consent.
Report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7)
Ability and willingness to complete all study visits and procedures
Agreement to engage with using the device on a daily basis

Key exclusion criteria (30 listed)

History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working)
Use of beta-blockers within 1 month of starting the study
Use of antidepressants or unstable dose within 3 months of starting study
Medication for anxiety (unless regime stable for last 3 months).

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
VeNSThe VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.	Device	Active, Sham

Primary outcome

Generalised Anxiety Disorder (GAD-7) Scores
Time frame: 4 weeks
To evaluate the effect of the VeNS device, relative to control group on participants with anxiety (range 0-21) with higher score indicating more severe anxiety.

3 secondary outcomes

Number of adverse events
Time frame: 4 weeks
Quality of life using SF-36 scores
Time frame: 4 weeks
Insomnia Severity Index (ISI) score
Time frame: 4 weeks

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 16 Jan 2024.
Derived from this study: PubMed 36901227Cheung T, Lam JYT, Fong KH, Ho YS, Ho A, Cheng CP, Sittlington J, Xiang YT, Li TMH. The Effectiveness of Electrical Vestibular Stimulation (VeNS) on Symptoms of Anxiety: Study Protocol of a Randomized, Double-Blinded, Sham-Controlled Trial. Int J Environ Res Public Health. 2023 Feb 27;20(5):4218. doi: 10.3390/ijerph20054218.
Individual participant dataSharing planned: No. Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.

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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.

Teris Cheung, PhD principal investigator

The Hong Kong Polytechnic University

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

Questions about this trial

What is this clinical trial studying?

A study testing VeNS in people with Anxiety, run by Neurovalens Ltd. at 1 site in Hong Kong.

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 9 inclusion and 30 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 16 Jan 2024. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?

Generalised Anxiety Disorder (GAD-7) Scores (time frame: 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 NCT04999709, 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 16 Jan 2024.