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

NCT ID: NCT04780893

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Active VeNS

Group Type: ACTIVE_COMPARATOR

Modius Sleep

Intervention Type: 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.

Sham VeNS

Group Type: SHAM_COMPARATOR

Modius Sleep

Intervention Type: 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.

Interventions

Modius Sleep

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinical Trial Mentors

INDUSTRY

Sponsor Role: collaborator

Neurovalens Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Mentors

Other Identifiers

NIPTSD01

Identifier Type: -

Identifier Source: org_study_id