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 range18 Years – 80 Years
SexALL
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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.
✓. Can speak/read Hindi or English
✓. 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