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

NCT06956118 | Recruiting

• 1 other identifier: NV-MS-2025-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

sleep; sleep quality; insomnia; Non-24 Sleep-Wake Disorder; quality of life; vestibular stimulation; neurostimulation

Outcome Measures

Primary Outcomes (2)

• Preliminary evidence of efficacy

  Change in Insomnia Severity Index (ISI) from baseline to week 4.

  4 weeks

• 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.

  4 weeks

Secondary Outcomes (2)

• Change in PSQI score from baseline to week 4.

  4 weeks

• Change in SF-36 from baseline to week 4.

  4 weeks

Study Arms (2)

Active VeNS Device

EXPERIMENTAL

The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will use the device under supervision at the clinical site for 30 minutes per day.

Device: Intervention (VeNS Stimulation) Device

Sham Device

SHAM COMPARATOR

The sham device looks identical to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will use the device under supervision at the clinical site for 30 minutes per day.

Device: Control (Sham Stimulation) Device

Interventions

Intervention (VeNS Stimulation) Device 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.

Active VeNS Device

Control (Sham Stimulation) Device 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.

Sham Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Neurovalens Ltd.: lead

Study Sites (1)

BGS MCH Hospital

Bengaluru, India

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sai Sailesh Kumar Goothy

  BGS MCH Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe Reel

CONTACT

+44 2890991835; trials@neurovalens.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)