Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT05845658
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7)
* Males or females 18-80 years of age inclusive on starting the study
* Can speak/read English
* Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device on a daily basis
* Not using, and have never used, prescription, or the counter, anxiety medications
* Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes
Exclusion Criteria:
* History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
* Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent the Modius Stress device from working)
* Medication for anxiety
* Use of beta-blockers within 1 month of starting the study
* Use of antidepressants or unstable dose within 3 months of starting study
* Use of any other medical condition or medication use that in the opinion of the PI is likely to make the participant resistant to VeNS.
* A score higher than 14 on the Insomnia Severity Index (ISI)
* A history of stroke or severe head injury (as defined by a head injury that required a craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation).
* 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 (a pregnancy kit can be mailed if any uncertainty)
* 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
* Diagnosis of a current psychotic disorder
* Regular use (more than twice a month) of antihistamine medication within the last 6 months.
* 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 myelodysplastic syndrome.
* Previous use of any VeNS device
* Participation in other clinical trials
* History of vestibular dysfunction or another inner ear disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
80 Years
Study:
NCT05845658
Study Brief:
Protocol Section:
NCT05845658