A Pilot Multicentric Clinical Trial to Evaluate the Impact of BeCurie Device on the Individuals with Poor Sleep Quality.

Aether Mindtech Solutions Pvt Ltd.0 个研究点目标入组 40 人开始时间: 待定最近更新: 2023年6月26日

试验速览

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•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.

•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.

发起方

Aether Mindtech Solutions Pvt Ltd.