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

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.

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 \