NCT02377817

Halifax PrenaBelt Trial

Completed NA Results posted Last updated 2 April 2020

What this trial tests

NA trial testing PrenaBelt in Sleep in 23 participants. Completed in 28 January 2017.

Timeline

15 March 2016

Primary endpoint
28 January 2017

28 January 2017

Quick facts

Lead sponsor	Allan Kember
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	prevention
Enrollment	23
Start date	15 March 2016
Primary completion	28 January 2017
Estimated completion	28 January 2017
Sites	1 location across Canada

Drugs / interventions tested

• PrenaBelt
• Sham PrenaBelt

Conditions studied

• Sleep — all drugs for Sleep →
• Pregnancy — all drugs for Pregnancy →
• Stillbirth — all drugs for Stillbirth →
• Infant, Low Birth Weight — all drugs for Infant, Low Birth Weight →

Sponsor

Allan Kember

Who can join

18 and older, female only, with Sleep or Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage (%) of Sleep Time Supine Primary · 1 night (approximately 8 hours)

Proportion of sleeping time spent in the supine position

Group	Value	95% CI
PrenaBelt Night	3.5	0.0 – 16.6
Sham PrenaBelt Night	16.4	3.5 – 25.3

Total Sleep Time Secondary · 1 night (approximately 8 hours)

This is a standard polysomnography measure of the amount of time the participant spent sleeping during the sleep test.

Group	Value	95% CI
PrenaBelt Night	353	318 – 376
Sham PrenaBelt Night	350	318 – 374

Supine Sleep Time Secondary · 1 night (approximately 8 hours)

The time (in minutes) spent sleeping in the supine position.

Group	Value	95% CI
PrenaBelt Night	12.3	0 – 53.5
Sham PrenaBelt Night	56.8	12.4 – 79.1

Left-lateral Sleep Time Secondary · 1 night (approximately 8 hours)

Time (in minutes) spent sleeping in the left-lateral position.

Group	Value	95% CI
PrenaBelt Night	185.6	± 102.5
Sham PrenaBelt Night	176.1	± 95.2

Right-lateral Sleep Time Secondary · 1 night (approximately 8 hours)

Time (in minutes) spent sleeping in the right-lateral position.

Group	Value	95% CI
PrenaBelt Night	108.9	± 110.1
Sham PrenaBelt Night	101.9	± 100.9

Percentage Sleep Left Secondary · 1 night (approximately 8 hours)

Percentage (%) of sleeping time in the left-lateral position.

Group	Value	95% CI
PrenaBelt Night	57.0	± 26.9
Sham PrenaBelt Night	52.2	± 27.0

Percentage Sleep Right Secondary · 1 night (approximately 8 hours)

Percentage (%) of sleeping time in the right-lateral position.

Group	Value	95% CI
PrenaBelt Night	31.3	± 28.8
Sham PrenaBelt Night	29.3	± 27.5

Sleep Latency Secondary · 1 night (approximately 8 hours)

This is a standard polysomnography measure of the amount of time (in minutes) that it takes a participant to transition from full wakefulness to sleep.

Group	Value	95% CI
PrenaBelt Night	11.7	6.7 – 21.9
Sham PrenaBelt Night	14.5	7.2 – 26.2

Sleep Efficiency Secondary · 1 night (approximately 8 hours)

This is a standard polysomnography measure of the percentage (%) of time the participant was asleep during the sleep test.

Group	Value	95% CI
PrenaBelt Night	81	76 – 89
Sham PrenaBelt Night	83	79 – 88

Total Arousal Index Secondary · 1 night (approximately 8 hours)

This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as a 'total arousal index', which is an average of the number of arousals per hour, and is further classified as a spontaneous, periodic leg movement, or respiratory arousal index.

Group	Value	95% CI
PrenaBelt Night	11.2	8.1 – 18.0
Sham PrenaBelt Night	12.0	8.5 – 15.6

Spontaneous Arousal Index Secondary · 1 night (approximately 8 hours)

This is a standard polysomnography measure of the number of times the participant was spontaneously aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as an 'arousal index', which is an average of the number of arousals per hour.

Group	Value	95% CI
PrenaBelt Night	10.5	± 5.8
Sham PrenaBelt Night	10.3	± 5.5

Periodic Limb Movement Arousal Index Secondary · 1 night (approximately 8 hours)

This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to periodic limb movements (PLMs). This is reported as an 'arousal index', which is an average of the number of arousals per hour.

Group	Value	95% CI
PrenaBelt Night	0	0 – 1.0
Sham PrenaBelt Night	0.1	0 – 0.7

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Modifying maternal sleep position in the third trimester of pregnancy with positional therapy: a randomised pilot trial.
   Kember AJ, Scott HM, O'Brien LM, Borazjani A, et al · · 2018 · cited 18× · PMID 30158217 · DOI 10.1136/bmjopen-2017-020256