Electrical Vestibular Nerve Stimulation (VeNS) as a Method of Sleep Management in People With PTSD

Study Overview
=================
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. Primary endpoint analysis will be performed at 4 weeks.

Official Title
-----------------
A Randomized, Double Blind Sham Controlled, Pilot Study to Evaluate the Efficacy of Vestibular Nerve Stimulation (VeNS) for Sleep Management in People With Post- Traumatic Stress Disorder (PTSD).

Conditions
-----------------
PTSD, Sleep Disturbance, Insomnia

Intervention / Treatment
-----------------
* Device: Modius Sleep


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active VeNS<br> | Device: Modius Sleep<br>* The device utilizes a technology called 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 30 minutes per day.<br>|
| Sham Comparator: Sham VeNS<br> | Device: Modius Sleep<br>* The device utilizes a technology called 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 30 minutes per day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) score | To evaluate the effect of the Modius Sleep 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCL-5 Score | To evaluate the effect of the Modius Sleep device, relative to control group, on the symptoms of PTSD, quantified by change in the PCL-5 Score. | 4 weeks | 
| SF-36 Score | To evaluate the effect of the Modius Sleep device, relative to control group, on quality of life, quantified by change in the SF-36 Score. | 4 weeks | 
| Generalised Anxiety Disorder (GAD-7) Scores | To evaluate the effect of the Modius Sleep device, relative to control group, on anxiety, quantified by change in the GAD-7 score. GAD-7 is a self-report rating scale assessing the severity of anxiety (range 0-21), with higher score indicating more severe anxiety. | 4 weeks | 
| Prescription reduction | To evaluate the effect of the Modius Sleep device, relative to control group, on prescription reduction, quantified by change in medication. | 4 weeks |