NCT06956118

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

Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients With Visual Impairment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Neurovalens Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients with Visual Impairment. Type of trial: A Pilot Randomized, Double-blind Sham-controlled Clinical Trial. Aim of the study: The aim of this pilot clinical trial is to evaluate the feasibility, safety and preliminary efficacy of VeNS compared to a Sham for improving sleep in individuals who are visually impaired. For this aim the clinical trial will evaluate the study retention rate, completion rate, adherence to the treatment regimen, and user experience questionnaire for acceptability measures (barriers, facilitators, participant burden, reasons for dropping out, satisfaction, perceptions). The study duration will be of 8 weeks with 4 weeks intervention and 4 weeks follow up. To determine the preliminary efficacy the study will measure the change in ISI from baseline to week 4 (Primary Outcome) and the Change in PSQI score and SF-36 (physical and mental component scores) from baseline to week 4 (Secondary Outcome). Safety will be evaluated by assessing the frequency and severity of adverse events (AEs) reported during the 4-week treatment period and the proportion of participants experiencing serious adverse events (SAEs) reported during the 4-week treatment period. Researchers will compare the real VeNS device to a sham device that looks the same but delivers no stimulation. Participants will: * Use either the VeNS or the sham device at the clinical site with supervision for 30 minutes every day during the 4-week intervention * Attend the 4 assessment visits where they will be assisted to fill in the required questionnaires for study data collection

Conditions

• Sleep Quality
• Quality of Lifte
• Non-24 Sleep-Wake Disorder

Interventions

Type	Name	Description
DEVICE	Intervention (VeNS Stimulation) Device	The Modius Sleep device is a non-invasive, battery-powered headset that delivers low-level electrical stimulation (up to 1.0 mA at 0.25 Hz) to the skin behind the ears over the mastoid processes. It is worn like headphones and used for 30 minutes per session, five times per week for four weeks, under clinical supervision. Participants are assisted by a staff member to position the electrodes and adjust stimulation intensity in 0.1 mA steps, up to a maximum of 1.0 mA. The headset is turned on manually, and participants are encouraged to set it up independently after initial guidance. Sessions take place while seated, and participants remain supervised throughout to ensure correct use and safety.
DEVICE	Control (Sham Stimulation) Device	The sham version of the Modius Sleep device is visually and operationally identical to the active device to preserve blinding. It delivers a brief initial stimulation (30 seconds, with a 20-second taper) at 0.8 Hz to mimic the sensation of the active device without providing ongoing vestibular modulation. The appearance, placement, and user experience are the same, and participants are informed that the sensation may fade during use. Like the intervention device, the sham is used under supervision in the clinic for 30-minute sessions, ensuring identical procedures across both groups. This design maintains blinding while minimizing any physiological effects from the sham stimulation.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-05-02
• Last updated: 2026-04-16

Locations

1 site across 1 country: India