Sleep Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have signed an informed consent form agreeing to take part in the study
• People aged between 20 and 60 years old at the time of signing the consent form
• People who score 5 or higher on a standard sleep quality questionnaire (called the PSQI) at the screening and baseline stages
• People who have been experiencing sleep problems for at least 3 months before the screening stage
• People who are severely sight impaired (very limited vision even at close range) or completely blind, as defined by specific vision measurement standards
• People who are able to attend the clinic with a family member or carer for the first study visit (a companion is encouraged for later visits, but study staff can assist if one is unavailable)
• People who can speak or read Hindi or English
• People who are willing and able to attend all study visits and follow the study procedures, including using the study device as instructed
• People who are able to attend the clinic for 30-minute sessions, 5 days a week, for the full 4-week treatment period
• People who agree not to make major lifestyle changes during the study that could affect sleep, such as significant changes to diet or exercise
• People who agree not to use any prescription or over-the-counter sleep medications during the trial, and who have not used any for at least 4 weeks before the trial starts
• People who agree not to use sleep-tracking devices or apps (such as smartwatches or Fitbits) during the study
• People who agree not to travel across multiple time zones during the study
• People who agree to keep their usual sleep environment and routine throughout the study, and who will not start or stop using any devices worn during sleep (such as a CPAP machine) during the study

Who may not be able to join:

• People who score below 5 on the PSQI sleep quality questionnaire at screening
• People with a history of skin breakdown, eczema, psoriasis, or other skin conditions affecting the skin behind the ears
• People who have been diagnosed with a long-term viral infection such as hepatitis or HIV
• People with a history of stroke or a serious head injury that required intensive care or brain surgery
• People currently diagnosed with a psychotic disorder
• People currently experiencing a diagnosed depressive episode
• People who have a permanently implanted battery-powered medical device, such as a pacemaker, implanted defibrillator, deep brain stimulator, or vagal nerve stimulator
• People who are pregnant, breastfeeding, or planning to become pregnant
• People with a history of epilepsy
• People with a history of migraines with aura
• People with a history of a serious head injury requiring intensive care or brain surgery
• People with a diagnosed condition affecting memory or thinking, such as Alzheimer's disease or dementia
• People with a history of bipolar disorder, psychotic disorders, or substance use disorders
• People who have used antihistamine medication more than twice a month in the last 6 months (confirm with trial site regarding switching to a non-drowsy antihistamine option)
• People with a history of cancer in the past year, except for certain types of minor skin cancers (confirm with trial site)
• People diagnosed with myelofibrosis or a myelodysplastic syndrome (blood or bone marrow conditions)
• People who have previously used a VeNS (vestibular nerve stimulation) device
• People who are currently participating in, or have previously participated in, other clinical trials run by Neurovalens or other insomnia studies
• People with any other medical condition or medication use that the lead investigator believes may prevent the device from working effectively
• People with a history of inner ear problems or vestibular dysfunction
• People living in the same household as someone who is currently or has previously taken part in a Neurovalens clinical study

Important: Always verify eligibility with the trial site directly before applying.