Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: BECURIE Device: BeCurie is a mental wellbeing device. Which is programmed to generate variable magnetic fields. That supports or improves the quality of sleep in Individuals with poor s
Sponsors
Aether Mindtech Solutions Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with poor quality of sleep (like difficulty in falling asleep, multiple awakening after falling asleep) for not more than 3 months. Subjects aged from 18 years to maximum of 70 years. Subjects willing to sign an ICF.
Exclusion criteria
Exclusion criteria: Having a significant health or psychiatric conditions/ disease that in the opinion of the investigator hinders active participation in the study. Severe Sleep Disorder or Severe Insomnia. Individuals with moderate to severe insomnia under medication. Subjects on antipsychotics or other medications that may cause insomnia. Having history of chronic drug or alcohol abuse. Skin related disorders like skin allergies or contact dermatitis. Pregnant women or lactating women. Contraindications to the device under investigation (skin irritability or allergy to electrode glue implanted devices as pacemakers or defibrillators. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject. A history of a serious medical condition such as cancers. History of allergy or hypersensitivity to any medical device or its components. Subjects enrolled in other clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in quality of sleep.Timepoint: On Day 15 as compared to baseline (Day 0) will be measured by the following based on a simple questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| ActigraphyTimepoint: Actigraphy is a wearable wrist band like watch. It is used to check the sleep reports. Actigraphy parameters Such as Sleep monitoring: Deep sleep, light sleep, rapid eye movement (REM), Sleep efficiency, Nocturnal wake time, Total nocturnal sleep time and the number of nocturnal awakenings. The data is captured at Day 1, Day 8 and Day 15â??th visit. Comparison from base line to the end of the study (Day 1 to Day 15). | — |
Countries
India
Contacts
Public ContactPV Shyam Sunder
Renova Neelima Hospitals
Outcome results
None listed