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

NCT04452981 | Completed DMC

• 1 other identifier: UUSS001
• Study Type: interventional
• Target: 153
• Locations: 2 countries
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Number of adverse events

  4 weeks

• Quality of life using SF-36 scores

  4 weeks

• Quality of sleep using PSQI

  4 weeks

Study Arms (2)

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.

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.

Device: VeNS

Interventions

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.

Active; Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Diagnosed insomnia with ISI of 15 or greater at screening
• Males or females
• 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)

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Neurovalens Ltd.: lead
• University of Ulster: collaborator
• The Hong Kong Polytechnic University: collaborator

Study Sites (2)

School of Nursing, The Hong Kong Polytechnic University

Hung Hom, Kowloon, HKSAR, Hong Kong

Location

University of Ulster

Coleraine, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40650353 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.

  PMID: 36834268 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Julie Sittlington, PhD

  University of Ulster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: June 15, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); HK (1)