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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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)
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Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joe Reel | Contact | +44 2890991835 | trials@neurovalens.com |
| Name | Affiliation | Role |
|---|---|---|
| Sai Sailesh Kumar Goothy | BGS MCH Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BGS MCH Hospital | Recruiting | Bengaluru | India |
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| 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. |
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| 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. | 4 weeks |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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