Modifying Maternal Sleep Position in the Third Trimester of Pregnancy With Positional Therapy: A Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Percentage (%) of Sleep Time Supine
研究概览
简要总结
Back and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature. Assuming that sleep position in pregnant women is modifiable, the same literature has indicated that this risk factor is modifiable; however, there is no evidence that this risk factor is truly modifiable.
The proposed link between back and right-sided sleeping position in a pregnant woman and LBW and SB of her baby is multifactorial; however, it ultimately implicates the woman's body position in causing compression of one of the large veins that brings blood back to her heart. This compression, along with other factors relating to the woman, her placenta, and her developing fetus, may result in decreased blood flow (nutrition and oxygen) to her developing baby, which, depending on the extent and duration, could result in LBW or SB of her baby. If the back sleeping position during pregnancy has a causative role in LBW and subsequently SB, the literature indicates that up to 17% of LBW and consequently 26% of SB could potentially be prevented by changing position to avoid back sleep. Note that 20 million LBW and 2.6 million SB occur each year worldwide.
Positional therapy (PT) is a safe and effective intervention for preventing people who snore or people who's breathing pauses during sleep from sleeping on their back - a position that makes their condition worse. The most basic form of PT modifies a person's sleeping position by either:
- Preventing them from sleeping on their back through restricting their movement, or
- Rather than restricting movement, significantly reducing the amount of time they spend sleeping on their back by applying pressure points to their body while they are on their back, which eventually causes them to shift into a different position and avoid lying on their back.
The purpose of this study is to evaluate the ability of a PT intervention to modify the position of pregnant women from their back and right side to their left side while they sleep in late pregnancy.
This study will help determine whether this potential risk factor is modifiable by way of a PT intervention, and whether it is feasible to intervene to reduce or prevent back and right-sided position sleep in late pregnancy. Demonstrating that the sleeping position of pregnant women can be modified through use of a simple, inexpensive PT intervention may be one of the keys to achieving significant reductions in LBW and late SB rates in Canada and worldwide.
详细描述
The utility of the PrenaBelt in modifying maternal sleeping position and the effect of the PrenaBelt on maternal respiratory and cardiovascular parameters during sleep and sleep staging in the third trimester of pregnancy will be evaluated via a two-night, randomized, cross-over, sham-controlled, triple-blind, sleep study in third trimester pregnant women.
Two nights: one night with a positional therapy (PT) device and one night with sham-PT device to determine treatment effect on outcomes.
Randomized: participants will be randomized to treatment order: sham-PT on first night, then PT on second night, or vice versa. This will avoid the potential impact of changes to sleep across the two nights resulting from familiarization with the equipment, which could bias the results.
Cross-over: on the second night, each participant will be crossed over from PT to sham-PT (or vice versa, depending on randomization order) to allow each participant to act as her own control for comparison of treatment effect on outcomes.
Sham-controlled: a sham-PT device that has the same fit and form of the PT device but without the ability of function (pressure points) will be used as a control. The purpose of a sham-PT device is to identify any specific benefit of one element of a PT device (e.g., fit or form) above and beyond all benefits that might be attributed to everything else about that device (e.g., function). Note that there is no established effective therapy for the population for the indication under study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥18 years old
- •low-risk singleton pregnancy
- •in the last trimester of pregnancy (≥28 weeks of gestation)
- •residing in the Halifax Regional Municipality
排除标准
- •BMI ≥ 35 at booking (first antenatal appointment for current pregnancy)
- •pregnancy complicated by obstetric complications (hypertension [pre-eclampsia, gestational hypertension, chronic hypertension], diabetes [gestational or not], or intra-uterine growth restriction [<10th %ile for growth])
- •sleep complicated by medical conditions (known obstructive sleep apnea, known to get <4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side [e.g., arthritic shoulder])
- •multiple pregnancy
- •known fetal abnormality
- •non-English speaking and reading
结局指标
主要结局
Percentage (%) of Sleep Time Supine
时间窗: 1 night (approximately 8 hours)
Proportion of sleeping time spent in the supine position
次要结局
- Supine Sleep Time(1 night (approximately 8 hours))
- Left-lateral Sleep Time(1 night (approximately 8 hours))
- Right-lateral Sleep Time(1 night (approximately 8 hours))
- Total Sleep Time(1 night (approximately 8 hours))
- Percentage Sleep Left(1 night (approximately 8 hours))
- Percentage Sleep Right(1 night (approximately 8 hours))
- Sleep Latency(1 night (approximately 8 hours))
- Sleep Efficiency(1 night (approximately 8 hours))
- Total Arousal Index(1 night (approximately 8 hours))
- Periodic Limb Movement Arousal Index(1 night (approximately 8 hours))
- Number of Participants With Snoring(1 night (approximately 8 hours))
- PrenaBelt User Feedback Questionnaire - Comfort(1 night (approximately 8 hours))
- Number of Position Changes(1 night (approximately 8 hours))
- Spontaneous Arousal Index(1 night (approximately 8 hours))
- Percent Stage 1 Sleep(1 night (approximately 8 hours))
- Percent Stage 3 Sleep(1 night (approximately 8 hours))
- Respiratory Arousal Index(1 night (approximately 8 hours))
- Percent Stage 2 Sleep(1 night (approximately 8 hours))
- Percent REM Sleep(1 night (approximately 8 hours))
- Apnea Hypopnea Index(1 night (approximately 8 hours))
- Respiratory Effort-Related Arousal Index(1 night (approximately 8 hours))
- Respiratory Disturbance Index (RDI)(1 night (approximately 8 hours))
- Peripheral Blood Oxygen Saturation (SpO2)(1 night (approximately 8 hours))
- PrenaBelt User Feedback Questionnaire - Satisfaction(1 night (approximately 8 hours))
- PrenaBelt User Feedback Questionnaire - Intention to Use(1 night (approximately 8 hours))
- Waking Position(1 night (approximately 8 hours))
- Sleep Onset Position(1 night (approximately 8 hours))
- Percentage of Total Sleep Time in Each Position(1 night (approximately 8 hours))
研究者
Allan Kember
Medical Student
IWK Health Centre