Actively Recruiting
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients
Led by Neurovalens Ltd. · Updated on 2026-04-16
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Male or female aged 20 to 60 years at consent
- PSQI score of 5 or higher at screening and baseline
- Sleep disorder symptoms lasting at least 3 months at screening
- Severely sight impaired (visual acuity less than 6/60 but at least 3/60 at 6 meters) or blind (visual acuity less than 3/60 at 6 meters)
- Accompanied by family member or carer at enrollment and initial visit; accompaniment encouraged at subsequent visits or assistance provided
- Able to speak and read Hindi or English
- Willing and able to complete all study visits and use the device as directed
- Willing and able to attend 30-minute stimulation sessions five days per week for four weeks
- Agree not to make extreme lifestyle changes affecting sleep during the study
- Agree not to use sleep medications during the trial and have not used them for 4 weeks before
- Agree not to use sleep trackers such as smart watches during the study
- Agree not to travel across multiple time zones during the study
- Agree to maintain familiar sleeping environment and routine and not start or stop using sleep devices during the study
You will not qualify if you...
- PSQI score less than 5 at screening
- Skin conditions affecting area behind the ears such as eczema or psoriasis
- History of chronic viral infections like hepatitis or HIV
- History of stroke or severe head injury requiring intensive care or neurosurgery
- Current diagnosis of psychotic disorders
- Current depressive episode
- Presence of permanently implanted battery-powered medical devices like pacemakers or stimulators
- Pregnancy, breastfeeding, or intending to become pregnant
- History of epilepsy
- History of active migraines with aura
- Diagnosis of cognitive impairment such as Alzheimer's disease or dementia
- History of bipolar, psychotic, or substance use disorders
- Regular antihistamine use more than twice a month in last 6 months without switching to non-drowsy alternatives
- History or presence of cancer within the last year except certain skin cancers
- Diagnosis of myelofibrosis or myelodysplastic syndrome
- Previous use of any VeNS device
- Participation in other Neurovalens-sponsored or insomnia clinical trials
- Any medical or medication condition likely to reduce response to VeNS
- History of vestibular dysfunction or inner ear disease
- Household member currently or previously in Neurovalens clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BGS MCH Hospital
Bengaluru, India
Actively Recruiting
Research Team
J
Joe Reel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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