Validation of SmartSnugg Infant Sleeping Bags

This study will validate a new product the SmartSnugg Baby Sleeping Bag that records the baby’s temperature and sleeping position while asleep and displays this for parents to check. The SmartSnugg uses a “pebble” which is contained in a pouch and is removable so it can be used in different sleeping bags and also for washing of the sleeping bag. The pebble incorporates an ambient temperate sensor, accelerometer and Ultra Low Power Bluetooth transmitter that communicates with a WIFI bridge in the child’s room. The WIFI bridge also incorporates an ambient temperature sensor so that the child’s room temperature can be monitored. The information captured from the pebble and bridge (temperature, movement, position) are received and routed from the SmartSnugg bridge through the users home WIFI network before being stored and analysed in the cloud. The information is then displayed to parents and caregivers on their mobile phone or tablet. The validation study will record temperature from accurate temperature sensors placed on the abdomen and limbs while the baby sleeps and compare these measurements to the output of the SmartSnugg. Sleep position and room temperature will also be confirmed. Recruitment: The study will be advertised on Monash University and Monash Health Newsletters and to local Maternal and Child Health Centre and Crèches. Parents of healthy babies aged 3 and 6 months will be invited to participate. Parents will contact Prof Horne and after discussion of the time commitments and methods to be used in the study she will email or post the parent information sheet. If parents agree to the research study a suitable time for the study will be scheduled. Parents will sign the parent information and consent form before the study commences. 20 healthy infants born at term will be recruited and studied at 3 months (n=10) and 6 months (n=10) of age. Methods: Infants will be studied in a quiet room at the Monash Children’s Hospital. Four different SmartSnugg Infant Sleeping Bags will be tested: 1. 0-3 month 1 tog 2. 0-3 month 2.5 tog 3. 3-12 month 1 tog 4. 3-12 month 2.5 tog. Infants will sleep have both a morning and afternoon sleep. They will sleep for 1-2 hours in each thickness of sleeping bag appropriate for their age. Studies will last 5-6 hours. Sleep state will be recorded using behavioural observations of eye movements and breathing and heart rate patterns as active sleep (AS) or quiet sleep (QS). Chest and abdominal wall motion (ProTech z-RIP belts, Pro-Tech Services, Inc. Mukilteo, WA, USA), pulse oxygen saturation (Masimo Radical, Masimo Corporation, CA, USA), oronasal airflow and nasal pressure (Compumedics, Melbourne, Vic, Australia) will be recorded to assess breathing patterns. Skin temperature will be recorded from the trunk and limbs (4 probes in total) (ADInstruments, Sydney, NSW, Australia). All signals will be recorded onto and E-series Sleep System (Compumedics, Melbourne, Vic, Australia). All studies will be transferred via EDF format to specialised analysis software PowerLab (Chart, ADInstruments, Sydney, NSW, Australia). Sleep state in infants will be scored as AS or QS according to standard criteria for infants. Apnoeas will be defined as those respiratory events lasting =3 s and will be classified as central, obstructive, or mixed apnoeas, central or obstructive hypopnoea. Periodic breathing episodes will be defined as 3 or more sequential central apnoeas lasting greater or equal to 3 s interrupted by breathing lasting greater or equal to 20 s. Total sleep time, sleep epoch lengths and the frequency of sleep state changes will be documented. Sleep position will be recorded. Infant skin temperature will be compared with the temperature recorded by the SmartSnugg with paired Student’s T-Tests. Data will be presented as mean ± SEM with a p value <0.05 take as being statistically significant. Baby weight will be recorded from infant health book. Expected Outcomes We expect that the temperature recorded by the SmartSnugg will not differ from that recorded from the infant.