The aim of the study is to collect video recordings which will be used retrospectively internally at Philips to test whether an algorithm can be used to measure the behavior and physiology of babies by using a camera and/or wearable. Development of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Het onderzoek heeft geen betrekking op een aandoening. In de studie werken we alleen met gezonde babys. De beoogde uiteindelijke toepassing zal ook alleen voor gezonde kinderen gebruikt mogen worden.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Can we measure baby behavior and physiology by camera and / or wearable?
- Video recordings will be made at the participants* home. These recordings
will be used afterwards to test if we are able to measure the behaviour and/or
of the baby.
Secondary outcome
Study 1:
- Can we measure breathing at all by camera when the baby is in bed?
- Can we measure when the baby is in and out of bed?
- Can we derive sleep stages from the data?
- Can we distinguish the baby (audio & movement) from other people near the bed
(i.e. parents and/or siblings)?
Background summary
Philips Research is investigating if it is possible to monitor the behavior and
physiology of babies using a camera and/or wearable to reassure parents w.r.t.
the behavior of their baby by using these devices. Monitoring algorithms can be
developed by analyzing video recordings of healthy babies in the home situation.
In this study data will be collected with either on-the-market devices (Baumer
camera, PC), modified devices (baby monitor, the only modification is making
the data available for storage so that the video can be analysed
retrospectively) and a prototype (Smartmattrass / Bender - DOC issued, the
matrass measures movement). The system will only collect data.
The data will be analysed after data collection has ended to investigate
whether it is possible to develop algorithms that can meet the requirements of
the secondary goals.
Study objective
The aim of the study is to collect video recordings which will be used
retrospectively internally at Philips to test whether an algorithm can be used
to measure the behavior and physiology of babies by using a camera and/or
wearable. Development of, and testing if the algorithm can perform, will be
done afterwards at Philips and not while recording are performed at the
participant*s home.
Study design
The study is an observational study. The collection of the recordings will be
done at the parents* home. Two cameras will be placed next to the baby*s bed.
Beneath the mattress of the bed, the smart mattress will be placed.
The two sessions per participant are as follows: During the first home visit a
couple of questions will be asked about the sleep behavior of the baby. The
baby-sleep-diary will be explained and the set-up will be installed next to the
baby bed. During the second home visit, parents will be asked for their
feedback and the set-up will be taken back to Philips. In between the two home
visits, recordings will be made of the baby bed and the baby when it is in bed.
The recordings will take 36-48 hours in total.
When a subject decides to stop the study participation, an extra subject will
be recruited to complete the data set.
Study burden and risks
The total time needed for the two home visits and filling in the baby sleep
diary will be two hours. Home visit 1 takes about 45 minutes, home visit 2
takes about 30 minutes. In between the 2 home visits, recordings will be made
of the baby bed and the baby while it is in bed for 48 hours maximum.
A risk analysis has been done for the study. The expected risk is low.
Interventions will not be done in this study. During the study video recordings
will be made using 2 cameras: a baby video monitor and a Baumer camera. The
software of the baby video monitor has been adapted for this study to be able
to store the recordings at the PC which is commercially available. The Baumer
camera is also commercially available. The smart mattress measures the movement
of the baby. The mattress is a prototype. A risk analysis has been done for
this device (see Technical file) and a Declaration of Conformity is available.
The burden for the baby is low. We don*t ask for a change in the daily rhythm
of the baby, we even want to keep the rhythm as it is. For the participation in
the study, the baby doesn*t have to do any extra actions.
Recordings will be screened, and if it is the case that there are recordings of
e.g. parents which are not dressed, the recordings with this information will
be deleted before storage for the analysis.
High Tech Campus 34
Eindhoven 5656 AE
NL
High Tech Campus 34
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
Participation in the study is possible when parents :
• Have a baby aged >3 weeks to 10 months;
• Have a baby who sleeps in its own bed (i.e. different sleeping surface than
parents; same room is allowed);
• Live in the Netherlands;.
• Are able to speak and read Dutch or English.
Exclusion criteria
Participation in the study is not possible when:
• the baby is under supervision of an Health Care professional because of
health, feeding or developmental problems;
• the parents or caregivers are unwilling or unable to provide informed consent
on behalf of you, your baby and other children.
• the parents or caregivers are unwilling or unable to comply with the study
requirements
• the parents or caregivers do not give permission to use their audio-video
image data recorded during the study as described in the information letter and
privacy notice
• the parents or caregivers are not able to fill in the questionnaires and baby
sleep diary
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79600.100.21 |
| Other | nog niet bekend, onder review |