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| Name | Class |
|---|---|
| University of Ulster | OTHER |
| The Hong Kong Polytechnic University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VeNS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | To evaluate the safety of the VeSTAL device relative to control group, in terms of the occurrence of adverse events. | 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Julie Sittlington, PhD | University of Ulster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, The Hong Kong Polytechnic University | Hung Hom | Kowloon | HKSAR | Hong Kong | ||
| University of Ulster |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40650353 | Derived | 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. | |
| 36834268 | Derived | Cheung 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. |
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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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 25, 2025 | |
| Reset | May 12, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 25, 2025 | May 12, 2025 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| 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. | 4 weeks |
| Coleraine |
| United Kingdom |
| D001523 |
| Mental Disorders |