Sleep QualityNCT06956118
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients
A study testing Intervention (VeNS Stimulation) Device in people with Sleep Quality and Quality of Lifte, run by Neurovalens Ltd. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Quality, Quality of Lifte, Non-24 Sleep-Wake Disorder
- What is being tested?
- Intervention (VeNS Stimulation) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2025to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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)
- -
Who cannot join
- 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
Show all 22Show fewer
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients With Visual Impairment
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.
Read more
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.
Read the 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
- Being tested
- Intervention (VeNS Stimulation) Device, Control (Sham Stimulation) Device
- Keywords
- sleep, sleep quality, insomnia, Non-24 Sleep-Wake Disorder, quality of life, vestibular stimulation, neurostimulation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention (VeNS Stimulation) DeviceDevice
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.
Control (Sham Stimulation) DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Control (Sham Stimulation) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary evidence of efficacy
Change in Insomnia Severity Index (ISI) from baseline to week 4.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Dec 2025
- Primary completion8 Sep 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sai Sailesh Kumar Goothy, Principal investigator, BGS MCH Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956118
- Sponsor's protocol ID
- NV-MS-2025-002
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients With Visual Impairment
- ClinicalTrials.gov ID
- NCT06956118
- Acronym / sponsor ID
- NV-MS-2025-002
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 8 Sep 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VeNS Device | Experimental | Device: Intervention (VeNS Stimulation) DeviceThe 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. |
| Sham Device | Sham comparator | Device: Control (Sham Stimulation) DeviceThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention (VeNS Stimulation) 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. | Device | Active VeNS Device |
| Control (Sham Stimulation) 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. | Device | Sham Device |
Primary outcome
Preliminary evidence of efficacy
Time frame: 4 weeks
Change in Insomnia Severity Index (ISI) from baseline to week 4.
Safety Outcome
Time frame: 4 weeks
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.
2 secondary outcomes
Change in PSQI score from baseline to week 4.
Time frame: 4 weeks
Change in SF-36 from baseline to week 4.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Sleep Quality
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruitingObservational study
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
Encephalopathy
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sai Sailesh Kumar Goothy principal investigator
BGS MCH Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (VeNS Stimulation) Device in people with Sleep Quality and Quality of Lifte, run by Neurovalens Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary evidence of efficacy (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.