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Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Insomnia

Primary Purpose

Insomnia, Sleep Disturbance

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VeNS
Sponsored by
Neurovalens Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Signed informed consent
  2. Diagnosed insomnia with ISI of 15 or greater at screening
  3. Males or females
  4. 18-80 years of age inclusive on starting the study
  5. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device on a daily basis
  6. Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial
  7. Agreement not to use sleep trackers for the duration of the study (e.g sleep app smart watches)
  8. Access to Wi-Fi (to connect iPod to internet)

Exclusion Criteria

  1. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears (image from participant required).
  2. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working)
  3. Medication for insomnia (unless regime stable for last 3 months).
  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. Pregnancy.
  7. Previous use of any VeNS device
  8. Participation in other clinical trials sponsored by Neurovalens
  9. Have a member of the same household who is currently participating in this study.
  10. History of vestibular dysfunction or other inner ear disease as indicated by the following screening questions:

Sites / Locations

  • School of Nursing, The Hong Kong Polytechnic University
  • University of Ulster

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active

Sham

Arm 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.

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.

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI) score
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.

Secondary Outcome Measures

Number of adverse events
To evaluate the safety of the VeSTAL device relative to control group, in terms of the occurrence of adverse events.
Quality of life using SF-36 scores
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.
Quality of sleep using PSQI
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.

Full Information

First Posted
June 26, 2020
Last Updated
February 21, 2023
Sponsor
Neurovalens Ltd.
Collaborators
University of Ulster, The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT04452981
Brief Title
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Insomnia
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
January 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurovalens Ltd.
Collaborators
University of Ulster, The Hong Kong Polytechnic University

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
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm 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 Title
Sham
Arm Type
Sham Comparator
Arm 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(s)
VeNS
Intervention 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.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI) score
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of adverse events
Description
To evaluate the safety of the VeSTAL device relative to control group, in terms of the occurrence of adverse events.
Time Frame
4 weeks
Title
Quality of life using SF-36 scores
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.
Time Frame
4 weeks
Title
Quality of sleep using PSQI
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.
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
No
Eligibility Criteria
Inclusion Criteria Signed informed consent Diagnosed insomnia with ISI of 15 or greater at screening Males or females 18-80 years of age inclusive on starting the study Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device on a daily basis Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial Agreement not to use sleep trackers for the duration of the study (e.g sleep app smart watches) Access to Wi-Fi (to connect iPod to internet) Exclusion Criteria History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears (image from participant required). Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working) Medication for insomnia (unless regime stable for last 3 months). 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.). Pregnancy. Previous use of any VeNS device Participation in other clinical trials sponsored by Neurovalens Have a member of the same household who is currently participating in this study. History of vestibular dysfunction or other inner ear disease as indicated by the following screening questions:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Sittlington, PhD
Organizational Affiliation
University of Ulster
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, The Hong Kong Polytechnic University
City
Hung Hom
State/Province
Kowloon
ZIP/Postal Code
HKSAR
Country
Hong Kong
Facility Name
University of Ulster
City
Coleraine
Country
United Kingdom

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 Treatment for Insomnia

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