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

Primary Purpose

PTSD, Sleep Disturbance, Insomnia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modius Sleep
Sponsored by
Neurovalens Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for PTSD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Active VeNS

    Sham VeNS

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    Prescription reduction
    To evaluate the effect of the Modius Sleep device, relative to control group, on prescription reduction, quantified by change in medication.

    Full Information

    First Posted
    June 26, 2020
    Last Updated
    August 8, 2022
    Sponsor
    Neurovalens Ltd.
    Collaborators
    Clinical Trial Mentors
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04780893
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    New trial opportunity in the USA.
    Study Start Date
    February 1, 2022 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Neurovalens Ltd.
    Collaborators
    Clinical Trial Mentors

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PTSD, Sleep Disturbance, Insomnia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active VeNS
    Arm Type
    Active Comparator
    Arm Title
    Sham VeNS
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Modius Sleep
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Insomnia Severity Index (ISI) score
    Description
    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.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    PCL-5 Score
    Description
    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.
    Time Frame
    4 weeks
    Title
    SF-36 Score
    Description
    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.
    Time Frame
    4 weeks
    Title
    Generalised Anxiety Disorder (GAD-7) Scores
    Description
    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.
    Time Frame
    4 weeks
    Title
    Prescription reduction
    Description
    To evaluate the effect of the Modius Sleep device, relative to control group, on prescription reduction, quantified by change in medication.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Wilson, MD
    Organizational Affiliation
    Clinical Trial Mentors
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.

    Learn more about this trial

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

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