PTSDNCT04780893
Electrical Vestibular Nerve Stimulation (VeNS) as a Method of Sleep Management in People With PTSD
A study testing Modius Sleep in people with PTSD and Sleep Disturbance, run by Neurovalens Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, Sleep Disturbance, Insomnia
- What is being tested?
- Modius Sleep
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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.
About this study
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).
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
- Being tested
- Modius Sleep
- Medical subject headings
- Stress Disorders, Post-Traumatic, Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modius SleepDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active VeNS | Active comparator | Not described Receives: Device: Modius Sleep |
| Sham VeNS | Sham comparator | Not described Receives: Device: Modius Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (4)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Prescription reduction
To evaluate the effect of the Modius Sleep device, relative to control group, on prescription reduction, quantified by change in medication.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Feb 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: New trial opportunity in the USA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Trial Mentors
- Responsible party
- Sponsor
- Investigators
- David Wilson, MD, Principal investigator, Clinical Trial Mentors
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780893
- Sponsor's protocol ID
- NIPTSD01
- Status last verified
- Jan 2024
- First submitted
- 26 Jun 2020
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04780893
- Acronym / sponsor ID
- NIPTSD01
- Conditions
- PTSD, Sleep Disturbance, Insomnia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New trial opportunity in the USA.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Clinical Trial Mentors
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VeNS | Active comparator | Device: Modius Sleep |
| Sham VeNS | Sham comparator | Device: Modius Sleep |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (16 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modius SleepThe 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. | Device | Active VeNS, Sham VeNS |
Primary outcome
Insomnia Severity Index (ISI) score
Time frame: 4 weeks
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 secondary outcomes
PCL-5 Score
Time frame: 4 weeks
SF-36 Score
Time frame: 4 weeks
Generalised Anxiety Disorder (GAD-7) Scores
Time frame: 4 weeks
Prescription reduction
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wilson, MD principal investigator
Clinical Trial Mentors
Questions about this trial
What is this clinical trial studying?
A study testing Modius Sleep in people with PTSD and Sleep Disturbance, run by Neurovalens Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.