InsomniaNCT04452981
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Insomnia
A study testing VeNS in people with Insomnia and Sleep Disturbance, run by Neurovalens Ltd. at 2 sites in 2 countries.
Trial summary
Insomnia is known to be one of the most common health concerns in in the general population and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for insomnia but their use is limited due to the risk of adverse events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Insomnia, Sleep Disturbance
- 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
- 153 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jun 2022to 3 Jan 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
- Diagnosed insomnia with ISI of 15 or greater at screening
- Males or females
- 18-80 years of age inclusive on starting the study
- Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device on a daily basis
- Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial
- Agreement not to use sleep trackers for the duration of the study (e.g sleep app smart watches)
- Access to Wi-Fi (to connect iPod to internet)
Who cannot join
- History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears (image from participant required).
- Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working)
- Medication for insomnia (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).
- Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
- Pregnancy.
Show all 10Show fewer
- Previous use of any VeNS device
- Participation in other clinical trials sponsored by Neurovalens
- Have a member of the same household who is currently participating in this study.
- History of vestibular dysfunction or other inner ear disease as indicated by the following screening questions:
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic University
Hung Hom, Kowloon, HKSAR
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 Insomnia.
Insomnia is known to be one of the most common health concerns in in the general population and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for insomnia but their use is limited due to the risk of adverse events. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of insomnia but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and sleep continues to be explored, however its usefulness in the treatment of insomnia 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 insomnia, 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. 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 insomnia.
- Conditions
- Insomnia, Sleep Disturbance
- Being tested
- VeNS
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Parasomnias
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 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.
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
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
Quality of sleep using PSQI
To evaluate the effect of the VeNS device, relative to control group, on quality of sleep quantified by change in the PSQI score. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score indicating worse sleep quality.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start15 Jun 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Ulster, The Hong Kong Polytechnic University
- Responsible party
- Sponsor
- Investigators
- Julie Sittlington, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452981
- Sponsor's protocol ID
- UUSS001
- Status last verified
- Jan 2024
- First submitted
- 26 Jun 2020
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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, Cheng CP, Xiang YT, Li TMH. Efficacy of electrical vestibular stimulation (VeNS) on adults with insomnia: A double-blind, randomized, sham-controlled trial. Dialogues Clin Neurosci. 2025 Dec;27(1):236-248. doi: 10.1080/19585969.2025.2526547. Epub 2025 Jul 11.
PubMed 40650353Cheung T, Lam JYT, Fong KH, Cheng CP, Ho A, Sittlington J, Xiang YT, Li TMH. Evaluating the Efficacy of Electrical Vestibular Stimulation (VeNS) on Insomnia Adults: Study Protocol of a Double-Blinded, Randomized, Sham-Controlled Trial. Int J Environ Res Public Health. 2023 Feb 17;20(4):3577. doi: 10.3390/ijerph20043577.
PubMed 36834268
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 Insomnia.
- ClinicalTrials.gov ID
- NCT04452981
- Acronym / sponsor ID
- UUSS001
- Conditions
- Insomnia, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Ulster, The Hong Kong Polytechnic University
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 1 Jul 2020 (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.
Insomnia is known to be one of the most common health concerns in in the general population and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for insomnia but their use is limited due to the risk of adverse events. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of insomnia but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and sleep continues to be explored, however its usefulness in the treatment of insomnia 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 insomnia, 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. 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 insomnia.
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 (8 listed)
- Signed informed consent
- Diagnosed insomnia with ISI of 15 or greater at screening
- Males or females
- 18-80 years of age inclusive on starting the study
- Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device on a daily basis
Key exclusion criteria (10 listed)
- History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears (image from participant required).
- Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working)
- Medication for insomnia (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).
- Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
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
Insomnia Severity Index (ISI) score
Time frame: 4 weeks
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.
3 secondary outcomes
Number of adverse events
Time frame: 4 weeks
Quality of life using SF-36 scores
Time frame: 4 weeks
Quality of sleep using PSQI
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 40650353Cheung T, Lam JYT, Fong KH, Cheng CP, Xiang YT, Li TMH. Efficacy of electrical vestibular stimulation (VeNS) on adults with insomnia: A double-blind, randomized, sham-controlled trial. Dialogues Clin Neurosci. 2025 Dec;27(1):236-248. doi: 10.1080/19585969.2025.2526547. Epub 2025 Jul 11.
- Derived from this study: PubMed 36834268Cheung T, Lam JYT, Fong KH, Cheng CP, Ho A, Sittlington J, Xiang YT, Li TMH. Evaluating the Efficacy of Electrical Vestibular Stimulation (VeNS) on Insomnia Adults: Study Protocol of a Double-Blinded, Randomized, Sham-Controlled Trial. Int J Environ Res Public Health. 2023 Feb 17;20(4):3577. doi: 10.3390/ijerph20043577.
- 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.
Julie Sittlington, PhD principal investigator
University of Ulster
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VeNS in people with Insomnia and Sleep Disturbance, run by Neurovalens Ltd. at 2 sites in 2 countries.
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 8 inclusion and 10 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 2 sites in Hong Kong, United Kingdom. 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?
Insomnia Severity Index (ISI) score (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 NCT04452981, which also lists 2 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 16 Jan 2024.