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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Sleep Quality, Quality of Lifte, Non-24 Sleep-Wake Disorder

In brief

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.

Key facts

Study ID: NCT06956118
Run by: Neurovalens Ltd.
People needed: 60
Starts: 2025-12-01
Expected to finish: 2026-06-01
Last updated by the study team: 2026-04-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Ability and willingness to attend the clinic for 30-minute stimulation sessions 5 days per week for the duration of the treatment period (4-weeks).
Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes
Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial and haven't for 4 weeks before the trial
Agreement not to use sleep trackers for the duration of the study (e.g. sleep app smart watches such as Fitbits)
Agree not to travel across multiple time-zones during the duration of the study
Agree to maintain a familiar sleeping environment/routine throughout the study and will not discontinue or begin treatment with new devices, used while sleeping, during the study (e.g. CPAP machines)

You may not qualify if…

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
Diagnosis of a current psychotic disorder
Suffering from a current characterized depressive episode
Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
Pregnancy or breast-feeding or intends to become pregnant
History of epilepsy
History of active migraines with aura
History of head injury requiring intensive care or neurosurgery
History of diagnosed cognitive impairment such as Alzheimer's disease/dementia
History of bipolar, psychotic or substance use disorders
Regular use (more than twice a month) of antihistamine medication within the last 6 month. The subject can opt to switch to Fexofenadine (non-drowsy) and may enroll after a wash-out period of 2 weeks.
History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
A diagnosis of myelofibrosis or a myelodysplastic syndrome.
Previous use of any VeNS device
Participation in other clinical trials sponsored by Neurovalens or other insomnia studies
Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
History of vestibular dysfunction or other inner ear disease
Member of the same household is currently or has previously participated in clinical study sponsored by Neurovalens

Where it is running

BGS MCH Hospital — Bengaluru, India (enrolling)

Full record on ClinicalTrials.gov

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