Clinical trial NCT04780893: Electrical Vestibular Nerve Stimulation (VeNS) as a Method of Sleep Management in People With PTSD
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).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Sleep Disturbance
Insomnia
Lead sponsor: Neurovalens Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Clinical Trial Mentors
First posted: 2021-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion criteria:

1. Signed informed consent
2. Diagnosed PTSD by a medical practitioner
3. Post-Traumatic Checklist (PCL-5) score of 31 or above
4. Insomnia Severity Index (ISI) score of 15 or above
5. Male or female, age ≥ 18 years and ≤ 80 years at the time of signing informed consent
6. Ability and willingness to complete all study visits and procedures, including completion of mental health questionnaires
7. Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the study
8. No change to PTSD, mental health or insomnia medication within the past 3 months (regimen should be stable)
9. Agreement not to change usage of prescription or over the counter PTSD, mental health or insomnia medications for the duration of the study
10. 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
11. Agreement not to use sleep trackers (e.g., Fitbit) for the duration of the study
12. Agreement not to travel across different time zones for the duration of the study
13. Access to Wi-Fi (to enable the study app to upload usage data)
14. Access to computer, laptop, iPad or tablet (to conduct remote study visits and complete study questionnaires remotely)
15. Willing to download and use Zoom (to conduct remote study visits)

Exclusion criteria:

1. History of skin breakdown, eczema, or other dermatological condition (e.g., psoriasis) affecting the skin behind the ears
2. Previous diagnosis of HIV infection or AIDS (HIV is known to cause vestibular neuropathy which would prevent VeNS from working)
3. Use of beta-blockers within 1 month of starting the study
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. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method
7. Diagnosis of epilepsy
8. Diagnosis of active migraines
9. Previous use of Modius device
10. Participation in other research studies sponsored by Neurovalens
11. Participation in any other sleep or PTSD studies
12. Not fluent in English language
13. Have a member of the same household who is currently participating in this study
14. Failure to agree to use of device daily during study participation
15. History of vestibular dysfunction or other inner ear disease
16. Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.

Primary outcomes:
measure: Insomnia Severity Index (ISI) score
timeFrame: 4 weeks
Secondary outcomes:
measure: PCL-5 Score
timeFrame: 4 weeks
measure: SF-36 Score
timeFrame: 4 weeks
measure: Generalised Anxiety Disorder (GAD-7) Scores
timeFrame: 4 weeks
measure: Prescription reduction
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Trial Mentors
name: David Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: