Clinical trial NCT04452981: Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Insomnia
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep Disturbance
Lead sponsor: Neurovalens Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Ulster
name: The Hong Kong Polytechnic University
First posted: 2020-07-01
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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:

Primary outcomes:
measure: Insomnia Severity Index (ISI) score
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of adverse events
timeFrame: 4 weeks
measure: Quality of life using SF-36 scores
timeFrame: 4 weeks
measure: Quality of sleep using PSQI
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
state: Kowloon
city: Coleraine
country: United Kingdom
facility: University of Ulster
Study officials:
affiliation: University of Ulster
name: Julie Sittlington, PhD
role: PRINCIPAL_INVESTIGATOR
References: