<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04452981</url>
  </required_header>
  <id_info>
    <org_study_id>UUSS001</org_study_id>
    <nct_id>NCT04452981</nct_id>
  </id_info>
  <brief_title>Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Insomnia</brief_title>
  <official_title>A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control For Treatment Of Insomnia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurovalens Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ulster</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Neurovalens Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Insomnia is known to be one of the most common health concerns in in the general population&#xD;
      and has been associated with several health consequences. Medications are known to be&#xD;
      effective, and currently serve as the primary treatment for insomnia but their use is limited&#xD;
      due to the risk of adverse events. Cognitive Behavioral Therapy (CBT-1) has also been shown&#xD;
      to be effective and safer in the treatment of insomnia but presents its own limitations such&#xD;
      as the time, cost, and training required. The relationship between vestibular stimulation and&#xD;
      sleep continues to be explored, however its usefulness in the treatment of insomnia is still&#xD;
      unknown. Vestibular stimulation itself has been shown to be safe across multiple populations.&#xD;
      If vestibular stimulation is shown to be effective in the treatment of insomnia, it could&#xD;
      serve as a safer alternative to medications. It could also require less cost, time, and&#xD;
      training than CBT-1, providing a treatment option that is not only safe and effective, but&#xD;
      broadly available to the general population. Consequently this trial seeks to evaluate the&#xD;
      efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving&#xD;
      sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with&#xD;
      insomnia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2022</start_date>
  <completion_date type="Actual">January 3, 2023</completion_date>
  <primary_completion_date type="Actual">January 3, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia Severity Index (ISI) score</measure>
    <time_frame>4 weeks</time_frame>
    <description>To evaluate the effect of the VeNS 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>4 weeks</time_frame>
    <description>To evaluate the safety of the VeSTAL device relative to control group, in terms of the occurrence of adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using SF-36 scores</measure>
    <time_frame>4 weeks</time_frame>
    <description>To evaluate the effect of the VeNS device, relative to control group, on quality of life. SF-36 is a 36-item short form survey (range 0-100) with higher scores indicating a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of sleep using PSQI</measure>
    <time_frame>4 weeks</time_frame>
    <description>To evaluate the effect of the VeNS device, relative to control group, on quality of sleep quantified by change in the PSQI score. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score indicating worse sleep quality.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Insomnia</condition>
  <condition>Sleep Disturbance</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The active device utilizes a technology termed 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 1 hour per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VeNS</intervention_name>
    <description>The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed 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 1 hour per day.</description>
    <arm_group_label>Active</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Signed informed consent&#xD;
&#xD;
          2. Diagnosed insomnia with ISI of 15 or greater at screening&#xD;
&#xD;
          3. Males or females&#xD;
&#xD;
          4. 18-80 years of age inclusive on starting the study&#xD;
&#xD;
          5. Ability and willingness to complete all study visits and procedures; in particular an&#xD;
             agreement to engage with trying to use the device on a daily basis&#xD;
&#xD;
          6. Agreement not to use prescription, or over the counter, sleep medications for the&#xD;
             duration of the trial&#xD;
&#xD;
          7. Agreement not to use sleep trackers for the duration of the study (e.g sleep app smart&#xD;
             watches)&#xD;
&#xD;
          8. Access to Wi-Fi (to connect iPod to internet)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis)&#xD;
             affecting the skin behind the ears (image from participant required).&#xD;
&#xD;
          2. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular&#xD;
             neuropathy which would prevent VeNS from working)&#xD;
&#xD;
          3. Medication for insomnia (unless regime stable for last 3 months).&#xD;
&#xD;
          4. A history of stroke or severe head injury (as defined by a head injury that required a&#xD;
             craniotomy or endotracheal intubation). (In case this damaged the neurological&#xD;
             pathways involved in vestibular stimulation).&#xD;
&#xD;
          5. Presence of permanently implanted battery powered medical device or stimulator (e.g.,&#xD;
             pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator&#xD;
             etc.).&#xD;
&#xD;
          6. Pregnancy.&#xD;
&#xD;
          7. Previous use of any VeNS device&#xD;
&#xD;
          8. Participation in other clinical trials sponsored by Neurovalens&#xD;
&#xD;
          9. Have a member of the same household who is currently participating in this study.&#xD;
&#xD;
         10. History of vestibular dysfunction or other inner ear disease as indicated by the&#xD;
             following screening questions:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie Sittlington, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ulster</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Nursing, The Hong Kong Polytechnic University</name>
      <address>
        <city>Hung Hom</city>
        <state>Kowloon</state>
        <zip>HKSAR</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ulster</name>
      <address>
        <city>Coleraine</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04452981
org study id: UUSS001
nct id: NCT04452981
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Insomnia is known to be one of the most common health concerns in in the general population
      and has been associated with several health consequences. Medications are known to be
      effective, and currently serve as the primary treatment for insomnia but their use is limited
      due to the risk of adverse events. Cognitive Behavioral Therapy (CBT-1) has also been shown
      to be effective and safer in the treatment of insomnia but presents its own limitations such
      as the time, cost, and training required. The relationship between vestibular stimulation and
      sleep continues to be explored, however its usefulness in the treatment of insomnia is still
      unknown. Vestibular stimulation itself has been shown to be safe across multiple populations.
      If vestibular stimulation is shown to be effective in the treatment of insomnia, it could
      serve as a safer alternative to medications. It could also require less cost, time, and
      training than CBT-1, providing a treatment option that is not only safe and effective, but
      broadly available to the general population. Consequently this trial seeks to evaluate the
      efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving
      sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with
      insomnia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Insomnia Severity Index (ISI) score
time frame: 4 weeks
description: To evaluate the effect of the VeNS 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.
measure: Number of adverse events
time frame: 4 weeks
description: To evaluate the safety of the VeSTAL device relative to control group, in terms of the occurrence of adverse events.
measure: Quality of life using SF-36 scores
time frame: 4 weeks
description: To evaluate the effect of the VeNS device, relative to control group, on quality of life. SF-36 is a 36-item short form survey (range 0-100) with higher scores indicating a better quality of life.
measure: Quality of sleep using PSQI
time frame: 4 weeks
description: To evaluate the effect of the VeNS device, relative to control group, on quality of sleep quantified by change in the PSQI score. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score indicating worse sleep quality.
arm group label: Active
arm group type: Active Comparator
description: The active device utilizes a technology termed 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 1 hour per day.
arm group label: Sham
arm group type: Sham Comparator
description: The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.
intervention type: Device
intervention name: VeNS
description: The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed 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 1 hour per day.
arm group label: Active
arm group label: Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Julie Sittlington, PhD
role: Principal Investigator
affiliation: University of Ulster
facility: 
facility: 
country: Hong Kong
country: United Kingdom
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Dyssomnias
mesh term: Parasomnias
sharing ipd: No
ipd 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.