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

Insomnia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452981
• Other study ID #: UUSS001
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: January 3, 2023

Study information

• Verified date: January 2024
• Source: Neurovalens Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria

1. Signed informed consent

2. Diagnosed insomnia with ISI of 15 or greater at screening

3. Males or females

4. 18-80 years of age inclusive on starting the study

5. 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

6. Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial

7. Agreement not to use sleep trackers for the duration of the study (e.g sleep app smart watches)

8. Access to Wi-Fi (to connect iPod to internet)

Exclusion Criteria

1. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears (image from participant required).

2. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working)

3. Medication for insomnia (unless regime stable for last 3 months).

4. 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).

5. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).

6. Pregnancy.

7. Previous use of any VeNS device

8. Participation in other clinical trials sponsored by Neurovalens

9. Have a member of the same household who is currently participating in this study.

10. History of vestibular dysfunction or other inner ear disease as indicated by the following screening questions:

Related Conditions & MeSH terms

• Dyssomnias
• Insomnia
• Parasomnias
• Sleep Disturbance
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• VeNS
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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The Hong Kong Polytechnic University	Hung Hom	Kowloon
United Kingdom	University of Ulster	Coleraine

Sponsors (3)

Lead Sponsor	Collaborator
Neurovalens Ltd.	The Hong Kong Polytechnic University, University of Ulster

Countries where clinical trial is conducted

Hong Kong,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	4 weeks
Secondary	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