Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Imp… (NCT06956118) | Clinical Trial Compass
RecruitingNot Applicable
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients
India60 participantsStarted 2025-12-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed Informed Consent
. Male or female, age ≥ 20 years and ≤ 60 years at the time of signing informed consent
. PSQI score ≥ 5 at screening and baseline
. Symptoms of sleep disorder lasting ≥ 3 months at the time of screening
. 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).
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
Exclusion criteria
. A PSQI score \< 5 at screening
. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
. Previous diagnosis of a chronic viral infection, for example hepatitis or HIV
. A history of stroke or severe head injury requiring intensive care or neurosurgery
. Diagnosis of a current psychotic disorder
. Suffering from a current characterized depressive episode
. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
. Pregnancy or breast-feeding or intends to become pregnant