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
Qualifiers
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
Treatments tested in this trial
- Intervention (VeNS Stimulation) Device
- Control (Sham Stimulation) Device
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov