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

NCT04780893 | Withdrawn DMC

• 1 other identifier: NIPTSD01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PTSD; Sleep Disturbance; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• PCL-5 Score

  4 weeks

• SF-36 Score

  4 weeks

• Generalised Anxiety Disorder (GAD-7) Scores

  4 weeks

• Prescription reduction

  4 weeks

Study Arms (2)

Active VeNS

ACTIVE COMPARATOR

Device: Modius Sleep

Sham VeNS

SHAM COMPARATOR

Device: Modius Sleep

Interventions

Modius Sleep DEVICE

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.

Active VeNS; Sham VeNS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurovalens Ltd.: lead
• Clinical Trial Mentors: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• David Wilson, MD

  Clinical Trial Mentors

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: March 4, 2021
• Study Start: February 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share