Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT06956118
Eligibility Criteria:
Inclusion Criteria: 1. Signed Informed Consent 2. Male or female, age ≥ 18 years and ≤ 80 years at the time of signing informed consent 3. PSQI score ≥ 5 at screening and baseline 4. Meets the DSM-5 for chronic insomnia at 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
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06956118
Study Brief:
Protocol Section:
NCT06956118