Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients

Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients With Visual Impairment

Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients with Visual Impairment.

This pilot clinical trial is testing whether a device called VeNS (vestibular nerve stimulation) can safely and effectively improve sleep in adults who are visually impaired.

The study will compare the active VeNS device to a sham (inactive) device. Participants will use the device under supervision for 30 minutes a day over 4 weeks, followed by a 4-week observation period. Researchers will assess sleep improvements, safety, and how acceptable and easy the treatment is for participants.

Allocation: Randomized to either active device or control device usage.

Endpoint classification: Efficacy Study

Intervention Model: Parallel Assignment in 1:1 active to control allocation

Sample size: The aim is to recruit a total of up to 60 participants. The study will last 8 weeks in total for each subject.

Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients with Visual Impairment.

Type of trial: A Pilot Randomized, Double-blind Sham-controlled Clinical Trial. Aim of the study: The aim of this pilot clinical trial is to evaluate the feasibility, safety and preliminary efficacy of VeNS compared to a Sham for improving sleep in individuals who are visually impaired.

For this aim the clinical trial will evaluate the study retention rate, completion rate, adherence to the treatment regimen, and user experience questionnaire for acceptability measures (barriers, facilitators, participant burden, reasons for dropping out, satisfaction, perceptions).

The study duration will be of 8 weeks with 4 weeks intervention and 4 weeks follow up. To determine the preliminary efficacy the study will measure the change in ISI from baseline to week 4 (Primary Outcome) and the Change in PSQI score and SF-36 (physical and mental component scores) from baseline to week 4 (Secondary Outcome). Safety will be evaluated by assessing the frequency and severity of adverse events (AEs) reported during the 4-week treatment period and the proportion of participants experiencing serious adverse events (SAEs) reported during the 4-week treatment period.

Researchers will compare the real VeNS device to a sham device that looks the same but delivers no stimulation.

Participants will:

• Use either the VeNS or the sham device at the clinical site with supervision for 30 minutes every day during the 4-week intervention
• Attend the 4 assessment visits where they will be assisted to fill in the required questionnaires for study data collection

Inclusion Criteria:

1. Signed Informed Consent

2. Male or female, age ≥ 20 years and ≤ 60 years at the time of signing informed consent

3. PSQI score ≥ 5 at screening and baseline

4. Symptoms of sleep disorder lasting ≥ 3 months at the time of screening

5. Severely Sight Impaired (defined as a visual acuity of < 6/60 but ≥3/60 at 6 meters) OR blind (defined as a visual acuity of <3/60 at 6 metres).

6. Participants must be accompanied by a family member or carer during the enrollment and initial study visit. For subsequent visits, accompaniment is encouraged; if a companion is unavailable, assistance will be provided by study staff or trained personnel.

7. Can speak/read Hindi or English

8. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device per the study protocol

9. Ability and willingness to attend the clinic for 30-minute stimulation sessions 5 days per week for the duration of the treatment period (4-weeks).

10. Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes

11. Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial and haven't for 4 weeks before the trial

12. Agreement not to use sleep trackers for the duration of the study (e.g. sleep app smart watches such as Fitbits)

13. Agree not to travel across multiple time-zones during the duration of the study

14. Agree to maintain a familiar sleeping environment/routine throughout the study and will not discontinue or begin treatment with new devices, used while sleeping, during the study (e.g. CPAP machines)

    -

Exclusion Criteria:

1. A PSQI score < 5 at screening

2. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.

3. Previous diagnosis of a chronic viral infection, for example hepatitis or HIV

4. A history of stroke or severe head injury requiring intensive care or neurosurgery

5. Diagnosis of a current psychotic disorder

6. Suffering from a current characterized depressive episode

7. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).

8. Pregnancy or breast-feeding or intends to become pregnant

9. History of epilepsy

10. History of active migraines with aura

11. History of head injury requiring intensive care or neurosurgery

12. History of diagnosed cognitive impairment such as Alzheimer's disease/dementia

13. History of bipolar, psychotic or substance use disorders

14. Regular use (more than twice a month) of antihistamine medication within the last 6 month. The subject can opt to switch to Fexofenadine (non-drowsy) and may enroll after a wash-out period of 2 weeks.

15. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)

16. A diagnosis of myelofibrosis or a myelodysplastic syndrome.

17. Previous use of any VeNS device

18. Participation in other clinical trials sponsored by Neurovalens or other insomnia studies

19. Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.

20. History of vestibular dysfunction or other inner ear disease

21. Member of the same household is currently or has previously participated in clinical study sponsored by Neurovalens

    -