Status:
WITHDRAWN
Electrical Vestibular Nerve Stimulation (VeNS) as a Method of Sleep Management in People With PTSD
Lead Sponsor:
Neurovalens Ltd.
Collaborating Sponsors:
Clinical Trial Mentors
Conditions:
PTSD
Sleep Disturbance
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This double blind randomized controlled study will enroll 20 subjects and will be conducted remotely. The study will be randomized for an 8-week period with a 1:1 active to sham device allocation. Pri...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Signed informed consent
- Diagnosed PTSD by a medical practitioner
- Post-Traumatic Checklist (PCL-5) score of 31 or above
- Insomnia Severity Index (ISI) score of 15 or above
- Male or female, age ≥ 18 years and ≤ 80 years at the time of signing informed consent
- Ability and willingness to complete all study visits and procedures, including completion of mental health questionnaires
- Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the study
- No change to PTSD, mental health or insomnia medication within the past 3 months (regimen should be stable)
- Agreement not to change usage of prescription or over the counter PTSD, mental health or insomnia medications for the duration of the study
- Agreement not to undergo any significant lifestyle changes that may affect sleep (e.g., excessive exercise, sleep interventions etc.) for the duration of the study
- Agreement not to use sleep trackers (e.g., Fitbit) for the duration of the study
- Agreement not to travel across different time zones for the duration of the study
- Access to Wi-Fi (to enable the study app to upload usage data)
- Access to computer, laptop, iPad or tablet (to conduct remote study visits and complete study questionnaires remotely)
- Willing to download and use Zoom (to conduct remote study visits)
- Exclusion criteria:
- History of skin breakdown, eczema, or other dermatological condition (e.g., psoriasis) affecting the skin behind the ears
- Previous diagnosis of HIV infection or AIDS (HIV is known to cause vestibular neuropathy which would prevent VeNS from working)
- Use of beta-blockers within 1 month of starting the study
- 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.)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method
- Diagnosis of epilepsy
- Diagnosis of active migraines
- Previous use of Modius device
- Participation in other research studies sponsored by Neurovalens
- Participation in any other sleep or PTSD studies
- Not fluent in English language
- Have a member of the same household who is currently participating in this study
- Failure to agree to use of device daily during study participation
- History of vestibular dysfunction or other inner ear disease
- Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
Exclusion
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04780893
Start Date
February 1 2022
End Date
April 1 2022
Last Update
January 16 2024
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