CTRI/2023/03/051108
Completed
Phase 3
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 sites40 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Aether Mindtech Solutions Pvt Ltd.
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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