Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNeurovalens Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention (VeNS Stimulation) Device
DeviceThe 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.
Control (Sham Stimulation) Device
DeviceThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active VeNS DeviceExperimental treatment 1 intervention
Group B: Sham DeviceSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Preliminary evidence of efficacy
Change in Insomnia Severity Index (ISI) from baseline to week 4.
Time frame
4 weeks2
Safety Outcome
Assess the frequency and severity of adverse events (AEs) reported during the 4-week treatment period. Assess the proportion of participants experiencing serious adverse events (SAEs) reported during the 4-week treatment period.
Time frame
4 weeksSecondary outcomes
1
Change in PSQI score from baseline to week 4.
Change in the Pittsburgh Sleep Quality Index (PSQI) (a validated, self-report questionnaire assessing sleep quality over a 1-month time period). The Index consists of nineteen items which generate seven subscores. The sum of scores for these seven components yields one total score. Each sub-score can range from 0 to 3 and the total score can range from 0 to 21. A total score of 5 or more indicates poor sleep quality; with a decrease in sleep quality reflected as the total score increases. The PSQI will be conducted at Screening/Week 0 and at week 4.
Time frame
4 weeks2
Change in SF-36 from baseline to week 4.
Change in SF-36 (physical and mental component scores) from baseline to week 4. The RAND 36-Item Short Form Health Survey (SF-36) is a validated self-report questionnaire assessing quality of life measures. The SF-36 has previously been tested for reliability and validity. The SF-36 will be conducted at Week 0 and Week 4.
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov