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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
| ActivInsights | UNKNOWN |
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To assess the ability of a machine learning algorithm to accurately detect fussing and crying time in infants using accelerometery data collected from a wearable device, compared to the Barr's parent-/caregiver-completed behaviour diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Initial data collection for device feasibility | Experimental | 3 subjects for 4 days included to collect initial data for algoritm development for device feasibility |
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| Part 2: Device feasibility | Experimental | 10 subjects for 7 days included to evaluate device feasibility |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActiveInsights accelerometer device | Device | Accelerometer device |
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| Measure | Description | Time Frame |
|---|---|---|
| Device feasibility: Comparison of device-generated versus diary-reported crying and fussing time data | Part 1: Comparison of daily crying and fussing time data generated by accelerometer and machine-learning versus crying and fussing time data reported by parental Barrs diary | 4 days |
| Device feasibility: Comparison of device-generated versus diary-reported crying and fussing time data | Part 2: Comparison of daily crying and fussing time data generated by accelerometer and machine-learning versus crying and fussing time data reported by parental Barrs diary | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Device feasibility: Comparison of device-generated versus diary-reported crying time data | Part 2: Comparison of daily crying time data generated by accelerometer and machine-learning versus crying time data reported by parental Barrs diary | 7 days |
| Device feasibility: Comparison of device-generated versus diary-reported fussing time data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianfranco Grompone, PhD | Contact | +46700019394 | gg@biogaia.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Clinical Trials | Recruiting | Cork | Ireland |
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| ID | Term |
|---|---|
| D018730 | Infant Behavior |
| ID | Term |
|---|---|
| D002652 | Child Behavior |
| D001519 | Behavior |
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Part 1: 3 subjects for 4 days included to collect initial data for algoritm development for device feasibility evaluation Part 2: 10 subjects for 7 days included to evaluate device feasibility
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Part 2: Comparison of daily fussing time data generated by accelerometer and machine-learning versus fussing time data reported by parental Barrs diary |
| 7 days |
| Device feasibility: Comparison of device-generated versus diary-reported sleeping time data | Part 2: Comparison of daily sleeping time data generated by accelerometer and machine-learning versus sleeping time data reported by parental Barrs diary | 7 days |