The primary aim of this test is to gather real-life data for development of a proposition to give feedback to parents on their baby 's sleep. In addition, we will also evaluate the proposition together with the parents that are participating in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening, onderzoek met gezonde deelnemers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are physiological and biomechanical signals and the
baby*s sleeping behaviour.
Secondary outcome
The qualitative information coming from the interviews at the end of the
recording period will be used for development of the embodiment of a consumer
product that will give feedback to the parents about the sleeping behaviour of
their child.
Background summary
We are aiming to support parents with developing healthy sleeping patterns for
their babies. In order to do so it is essential to give the parent more insight
into the sleeping behaviour of their little one. Hence, we need to measure this
sleeping behaviour in a home setting in a way that is acceptable for parents.
Study objective
The primary aim of this test is to gather real-life data for development of a
proposition to give feedback to parents on their baby 's sleep. In addition, we
will also evaluate the proposition together with the parents that are
participating in the study.
Study design
Babies will be monitored during bedtime for 7 consecutive days/nights, in
their own baby bedroom to measure physiological and biomechanical signals. No
obligatory interventions will take place, and as such this can be regarded an
observational study.
Study burden and risks
The study needs to be carried out with baby*s aged between 1 and 12 months,
because we are aiming to develop a proposition that is specified for this
target group, and their sleep behavior and body characteristics are clearly
distinct from other age groups.
The risks involved in this study are minimized as well as the burden for the
baby and their parents. Parents will be asked to switch on the measurements
before the baby goes to sleep and switch them off when they take the baby out
of bed. In addition, we will ask for their feedback and suggestions for
improvement. This requires active involvement from their side, which takes time
from the busy parent and can be seen as a potential burden. However, this
active participation may also be very rewarding since they contribute to
development of products that they, or other parents, might profit from in the
future.
High Tech Campus 34
Eindhoven 5656 AE
NL
High Tech Campus 34
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
Healthy term babies aged between 1-12 months who are mild problem sleepers defined based on the Brief Infant Sleep Questionnaire (BISQ) as follows: baby's that display at least 3 days during the week the following behavior: >2 wake-up times per night, or >half an hour in wakefulness during the night. Only babies who are used to sleeping in their own bed and bedroom will be included in the study.
Exclusion criteria
Infants will be excluded from participation in case they suffer from any medical complaint.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50539.028.14 |