Vestibular nerve stimulation to improve sleep in people with visual impairment
Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients With Visual Impairment
This study will test whether a small device that stimulates the vestibular (balance) nerves can help adults who are blind or severely visually impaired sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Neurovalens Ltd. Industry-sponsored |
| Locations | 1 site (Bengaluru) |
| Trial ID | NCT06956118 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, sham-controlled pilot will compare active VeNS to an identical-appearing inactive device in up to 60 adults with severe sight impairment or blindness over an 8-week period (4 weeks of supervised daily stimulation and 4 weeks of follow-up). Participants attend the clinic for 30-minute stimulation sessions five days per week during the treatment phase, with 1:1 parallel allocation to active or sham. The primary outcome is change in Insomnia Severity Index (ISI) from baseline to week 4, with secondary outcomes including PSQI and SF-36 changes, feasibility measures (retention, adherence, acceptability), and safety (adverse events). The sham device delivers no stimulation and investigators will compare sleep and quality-of-life measures between groups to determine preliminary efficacy and tolerability.
Who should consider this trial
Good fit: Adults aged 20–60 with chronic sleep problems (PSQI ≥5) who are severely sight impaired or blind and can attend supervised 30-minute clinic sessions five days per week.
Not a fit: People with milder visual impairment, those unable to attend frequent clinic visits, or whose sleep problems are primarily caused by untreated medical or psychiatric conditions may not benefit from this intervention.
Why it matters
Potential benefit: If successful, VeNS could offer a non-drug option to improve sleep quality and daytime functioning for visually impaired adults.
How similar studies have performed: Prior small mechanistic and pilot studies of vestibular or other peripheral neuromodulation suggest possible sleep or circadian effects, but randomized evidence in visually impaired patients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Signed Informed Consent
2. Male or female, age ≥ 20 years and ≤ 60 years at the time of signing informed consent
3. PSQI score ≥ 5 at screening and baseline
4. Symptoms of sleep disorder lasting ≥ 3 months at the time of screening
5. 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).
6. 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.
7. Can speak/read Hindi or English
8. 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
9. 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).
10. Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes
11. 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
12. Agreement not to use sleep trackers for the duration of the study (e.g. sleep app smart watches such as Fitbits)
13. Agree not to travel across multiple time-zones during the duration of the study
14. 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:
1. A PSQI score \< 5 at screening
2. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
3. Previous diagnosis of a chronic viral infection, for example hepatitis or HIV
4. A history of stroke or severe head injury requiring intensive care or neurosurgery
5. Diagnosis of a current psychotic disorder
6. Suffering from a current characterized depressive episode
7. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
8. Pregnancy or breast-feeding or intends to become pregnant
9. History of epilepsy
10. History of active migraines with aura
11. History of head injury requiring intensive care or neurosurgery
12. History of diagnosed cognitive impairment such as Alzheimer's disease/dementia
13. History of bipolar, psychotic or substance use disorders
14. 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.
15. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
16. A diagnosis of myelofibrosis or a myelodysplastic syndrome.
17. Previous use of any VeNS device
18. Participation in other clinical trials sponsored by Neurovalens or other insomnia studies
19. Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
20. History of vestibular dysfunction or other inner ear disease
21. Member of the same household is currently or has previously participated in clinical study sponsored by Neurovalens
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Where this trial is running
Bengaluru
- BGS MCH Hospital — Bengaluru, India (Recruiting)
Study contacts
- Principal investigator: Sai Sailesh Kumar Goothy — BGS MCH Hospital
- Study coordinator: Joe Reel
- Email: trials@neurovalens.com
- Phone: +44 2890991835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.