MedTrace Logo

Baby Breathing Monitoring @Home

NCT05175560 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2022-11-01

No results posted yet for this study

Summary

To give reassurance to parents, Philips would like to add algorithms to the NightOwl baby monitor to be able to measure baby behavior and physiology.

In this study, the investigators aim to investigate the applicability of in-house breathing algorithms, and to develop algorithms, for babies sleeping in a home setting.

The data collection will be divided in several sub-studies, either e.g. matching different development steps in the development of the algorithm or focusing on a specific baby population (e.g. specific age range). In general, babies will be monitored (audio, video, activity) for 24 -48 hours under their habitual sleeping conditions.

Step 1: 3 full data sets will be recorded of babies in bed aged 3 weeks to about 3-4 months, who are not able to turn over yet. Data will be analyzed and study set-up will be checked. Parents will be asked to keep a baby sleep diary and a questionnaire will be filled in at the start, with questions regarding the sleep behavior of their child. At the end, parents will be asked to fill in a questionnaire with sleep-related and feedback questions.

In step 2, 5 full data sets will be collected following the same procedure as step 1.

In step 3 12 full data sets will be collected following the same procedure as step 1.

After each step, the study setup including the algorithms, will be reviewed based on the obtained data. All modifications to this protocol will be submitted as amendments.

After step 1 and 2, the Mother and Child Care Business unit of Philips and other relevant stakeholders will be updated on the progress and findings by means of a (short) meeting and PowerPoint slides.

After step 3, a report will be written. The PowerPoint slides shared after Step 1 and 2 will be incorporated in this report.

Conditions

  • Healty Babies
  • 3 Weeks - 3 Months Old

Sponsors & Collaborators

  • Philips Electronics Nederland B.V. acting through Philips CTO organization

    lead INDUSTRY

Principal Investigators

  • Renee Otte, dr · Philips Electronics Nederland B.V. acting through Philips CTO organization

Eligibility

Min Age
3 Weeks
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2022-09-06
Completion
2022-10-10

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT05175560 on ClinicalTrials.gov