Clinical trial NCT02377817: Halifax PrenaBelt Trial
Official title: Modifying Maternal Sleep Position in the Third Trimester of Pregnancy With Positional Therapy: A Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Pregnancy
Stillbirth
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Very Low Birth Weight
Fetal Growth Retardation
Fetal Hypoxia
Keywords: positional therapy
tennis ball technique
sleep in pregnancy
supine
polysomnography
sleep position
supine position
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Innovative Canadians for Change
name: Global Innovations for Reproductive Health and Life
name: Kaishin Chu Design
name: Nova Scotia Health Authority
name: University of Michigan
name: Harvard University
First posted: 2015-03-04
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Triple blind: participants, sleep technologists monitoring and scoring the sleep tests, and the specialized sleep physician reviewing and reporting the sleep test results will be blinded to the intervention received each night.

Laboratory: conducting this study in a controlled lab setting will allow for continual, real time monitoring of various cardiovascular, respiratory, and sleep parameters of each participant by the sleep technologist. This contributes to a more controlled and safer study overall.

Sleep test: body position, various cardiovascular and respiratory parameters, and sleep parameters will be continuously recorded while the participants are sleeping. Sleep lab procedures will be followed by the personnel conducting, scoring, reviewing, and reporting the sleep tests from participant preparation through discharge

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* low-risk singleton pregnancy
* in the last trimester of pregnancy (≥28 weeks of gestation)
* residing in the Halifax Regional Municipality

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage (%) of Sleep Time Supine
timeFrame: 1 night (approximately 8 hours)
Secondary outcomes:
measure: Total Sleep Time
timeFrame: 1 night (approximately 8 hours)
measure: Supine Sleep Time
timeFrame: 1 night (approximately 8 hours)
measure: Left-lateral Sleep Time
timeFrame: 1 night (approximately 8 hours)
measure: Right-lateral Sleep Time
timeFrame: 1 night (approximately 8 hours)
measure: Percentage Sleep Left
timeFrame: 1 night (approximately 8 hours)
measure: Percentage Sleep Right
timeFrame: 1 night (approximately 8 hours)
measure: Sleep Latency
timeFrame: 1 night (approximately 8 hours)
measure: Sleep Efficiency
timeFrame: 1 night (approximately 8 hours)
measure: Total Arousal Index
timeFrame: 1 night (approximately 8 hours)
measure: Spontaneous Arousal Index
timeFrame: 1 night (approximately 8 hours)
measure: Periodic Limb Movement Arousal Index
timeFrame: 1 night (approximately 8 hours)
measure: Respiratory Arousal Index
timeFrame: 1 night (approximately 8 hours)
measure: Percent Stage 1 Sleep
timeFrame: 1 night (approximately 8 hours)
measure: Percent Stage 2 Sleep
timeFrame: 1 night (approximately 8 hours)
measure: Percent Stage 3 Sleep
timeFrame: 1 night (approximately 8 hours)
measure: Percent REM Sleep
timeFrame: 1 night (approximately 8 hours)
measure: Apnea Hypopnea Index
timeFrame: 1 night (approximately 8 hours)
measure: Respiratory Effort-Related Arousal Index
timeFrame: 1 night (approximately 8 hours)
measure: Respiratory Disturbance Index (RDI)
timeFrame: 1 night (approximately 8 hours)
measure: Peripheral Blood Oxygen Saturation (SpO2)
timeFrame: 1 night (approximately 8 hours)
measure: Number of Participants With Snoring
timeFrame: 1 night (approximately 8 hours)
measure: PrenaBelt User Feedback Questionnaire - Satisfaction
timeFrame: 1 night (approximately 8 hours)
measure: PrenaBelt User Feedback Questionnaire - Comfort
timeFrame: 1 night (approximately 8 hours)
measure: PrenaBelt User Feedback Questionnaire - Intention to Use
timeFrame: 1 night (approximately 8 hours)
measure: Sleep Onset Position
timeFrame: 1 night (approximately 8 hours)
measure: Waking Position
timeFrame: 1 night (approximately 8 hours)
measure: Number of Position Changes
timeFrame: 1 night (approximately 8 hours)
measure: Percentage of Total Sleep Time in Each Position
timeFrame: 1 night (approximately 8 hours)
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Women's Health Centre
state: Nova Scotia
Study officials:
affiliation: The IWK Health Centre
name: Heather Scott, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Owusu JT, Anderson FJ, Coleman J, Oppong S, Seffah JD, Aikins A, O'Brien LM. Association of maternal sleep practices with pre-eclampsia, low birth weight, and stillbirth among Ghanaian women. Int J Gynaecol Obstet. 2013 Jun;121(3):261-5. doi: 10.1016/j.ijgo.2013.01.013. Epub 2013 Mar 15.
citation: Stacey T, Thompson JM, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan LM. Association between maternal sleep practices and risk of late stillbirth: a case-control study. BMJ. 2011 Jun 14;342:d3403. doi: 10.1136/bmj.d3403.
citation: Gordon A, Raynes-Greenow C, Bond D, Morris J, Rawlinson W, Jeffery H. Sleep position, fetal growth restriction, and late-pregnancy stillbirth: the Sydney stillbirth study. Obstet Gynecol. 2015 Feb;125(2):347-355. doi: 10.1097/AOG.0000000000000627.
citation: Platts J, Mitchell EA, Stacey T, Martin BL, Roberts D, McCowan L, Heazell AE. The Midland and North of England Stillbirth Study (MiNESS). BMC Pregnancy Childbirth. 2014 May 21;14:171. doi: 10.1186/1471-2393-14-171.
citation: Warland J, Mitchell EA. A triple risk model for unexplained late stillbirth. BMC Pregnancy Childbirth. 2014 Apr 14;14:142. doi: 10.1186/1471-2393-14-142.
citation: O'Brien LM, Warland J. Typical sleep positions in pregnant women. Early Hum Dev. 2014 Jun;90(6):315-7. doi: 10.1016/j.earlhumdev.2014.03.001. Epub 2014 Mar 21.
citation: Kember AJ, Scott HM, O'Brien LM, Borazjani A, Butler MB, Wells JH, Isaac A, Chu K, Coleman J, Morrison DL. Modifying maternal sleep position in the third trimester of pregnancy with positional therapy: a randomised pilot trial. BMJ Open. 2018 Aug 29;8(8):e020256. doi: 10.1136/bmjopen-2017-020256.