Status:
COMPLETED
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Insomnia
Lead Sponsor:
Neurovalens Ltd.
Collaborating Sponsors:
University of Ulster
The Hong Kong Polytechnic University
Conditions:
Insomnia
Sleep Disturbance
Eligibility:
All Genders
18-80 years
Phase:
NA
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 current...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Signed informed consent
- Diagnosed insomnia with ISI of 15 or greater at screening
- Males or females
- 18-80 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)
- Exclusion Criteria
- 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:
Exclusion
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2023
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04452981
Start Date
June 15 2022
End Date
January 3 2023
Last Update
January 16 2024
Active Locations (2)
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1
School of Nursing, The Hong Kong Polytechnic University
Hung Hom, Kowloon, Hong Kong, HKSAR
2
University of Ulster
Coleraine, United Kingdom