None listed
Conditions
Brief summary
The aim of this study is to test the effectiveness of a new pillow designed to decrease the amount of time pregnant women spend sleeping on their back. This study will involve two conditions for each woman: one week using the new pillow and one week without the pillow, each ending with a night of overnight sleep monitoring. The sleep monitoring will (i) measure body position throughout the night to establish whether the new pillow is preventing back sleeping, and (ii) to determine if the pillow is comfortable and encourages better sleep. Importantly, we will (iii) perform fetal heart rate monitoring during the night to compare whether there are measurable differences in the baby's heart rate between these two settings. This study will help us to determine the impact of sleeping on your back during pregnancy, and whether we can encourage a safer sleeping position.
Interventions
This pilot study will be a randomized cross-over repeated measures study of an intervention to prevent supine sleep in pregnancy. A total of 40 participants will be randomized to receive either the intervention (Back-Off Pillow) or no intervention (control) for the first week and will be crossed over to the alternate regimen on the second week. During the intervention week, the participant will be asked to use the pillow at home each night for the whole sleep period. During each week, the par
This pilot study will be a randomized cross-over repeated measures study of an intervention to prevent supine sleep in pregnancy. A total of 40 participants will be randomized to receive either the intervention (Back-Off Pillow) or no intervention (control) for the first week and will be crossed over to the alternate regimen on the second week. During the intervention week, the participant will be asked to use the pillow at home each night for the whole sleep period. During each week, the participant will wear the Night Shift Sleep Positioner during sleep, which will record their body position overnight. At the end of each week the participant will undergo a level 3 sleep study with the WatchPAT 300 in their own homes, and participants will wear the Monica AN24 during the sleep period which will continuously monitor the fetal heart rate (CTG – cardiotocography). The Back-Off Pillow is a U-shaped pillow designed to prevent rolling onto the back during sleep. One arm of the pillow is firm and supports the back, whilst the other arm is softer for resting the arms/body. Participants will complete a sleep diary for each night of the study, which will include details of adherence to the pillow.
Sponsors
Institute for Breathing and Sleep
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants enrolled into the study will be low risk women with a singleton pregnancy in the third trimester (>28 weeks gestation) without known fetal abnormalities, who are aged 18 years or older, and capable of giving informed consent.
Exclusion criteria
Known fetal abnormalities, aged 18 years or less, unable to give informed consent.
Outcome results
None listed