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New treatment option for Sleep Quality
Official title Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients
ClinicalTrials.gov ID: NCT06956118
What this study is testing
- What it's testing
- 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.
- Time commitment: about 8 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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).
You likely can't join 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
See the full eligibility 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...
- 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) \-
- 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 \-
The study team makes the final eligibility decision.
Where it's taking place
- Bengaluru, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengaluru, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.