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

Neurovalens

Status: Completed

Conditions: Insomnia; Sleep Disturbance

Treatments: Device: VeNS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04452981

UUSS001

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

153 participants in 2 patient groups

Active

Active Comparator group

Description:

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.

Treatment:

Device: VeNS

Sham

Sham Comparator group

Description:

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.

Treatment:

Device: VeNS