Status:
COMPLETED
Novel Objective Digital Biomarkers for Assessing Sub-clinical Mood Disturbances in the Singaporean Population
Lead Sponsor:
Institute for Human Development and Potential (IHDP), Singapore
Collaborating Sponsors:
OBVIO HEALTH USA, Inc.
Conditions:
Mood
Eligibility:
All Genders
21-30 years
Phase:
NA
Brief Summary
The investigators aim to assess the relationship between objectives markers (of physiological reactivity) recorded using a smartwatch and self-reported subjective outcomes measured using standardized ...
Eligibility Criteria
Inclusion
- Aged 21 to 30 years
- Own and uses a smartphone that is capable of running the study applications
- Have access to the internet
- Adequate fluency in the English language to understand the informed consent process, study instructions and study assessments
- Sufficient vision and hearing to complete study procedures
- Willing to commit to about 20 minutes of assessments each day for a period of 8 days
- Willing to wear selected study devices 24 hours/day; 7-days per week with only occasional relief
- Willing and able to participate and to give written informed consent
Exclusion
- Past (\< 6 months prior to the study) or current neurological or psychiatric condition
- Past (\< 3 months prior to the study) or current use of psychoactive medication
- Having received antibiotic treatment \< 4 weeks prior to the study
- Present or past history of alcohol or drug addiction and/or recreational drug use
- Maltodextrin allergy
- Members of the research team or their immediate family members. An immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted
- Women participants who are currently pregnant or have been pregnant in past 6 months
Key Trial Info
Start Date :
August 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06115590
Start Date
August 24 2023
End Date
February 18 2024
Last Update
August 16 2024
Active Locations (1)
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1
Singapore Institute for Clinical Trials
Singapore, Singapore, 117609