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Validation of Active-Insights Device to Measure Crying Time

NCT05165589 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-12-21

No results posted yet for this study

Summary

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.

Conditions

  • Infant Behavior

Interventions

DEVICE

ActiveInsights accelerometer device

Accelerometer device

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • ActivInsights

    collaborator UNKNOWN

  • BioGaia AB

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-01-31
Completion
2022-04-30

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05165589 on ClinicalTrials.gov