SleepNCT02377817

Halifax PrenaBelt Trial

A study testing PrenaBelt in people with Sleep and Pregnancy, run by Allan Kember at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Sleep, Pregnancy, Stillbirth
What is being tested?: PrenaBelt
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteCanada
Study dates: 15 Mar 2016to 28 Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

IWK Women's Health Centre
Halifax, Nova Scotia, B3K 6R8

Other trials in Canada

About this study

Official title: Modifying Maternal Sleep Position in the Third Trimester of Pregnancy With Positional Therapy: A Randomized Pilot Trial

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.

Read the 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

Conditions: Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Very Low Birth Weight
Being tested: PrenaBelt, Sham PrenaBelt
Keywords: positional therapy, tennis ball technique, sleep in pregnancy, supine, polysomnography, sleep position, supine position
Medical subject headings: Stillbirth, Fetal Growth Retardation, Fetal Hypoxia, Deception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrenaBeltDevice
The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. PT is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition.
The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back and right side of the user when she lies on her back or right side, respectively, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back or right side.
Sham PrenaBeltDevice
The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.

Study groups in NCT02377817
Study group	Role	What they receive
PrenaBelt on First Sleep Test Night	Experimental	Participants will be randomized to treatment order: sham PrenaBelt on first night, then PrenaBelt 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 polysomnography equipment, which could bias the results. Receives: Device: PrenaBelt; Device: Sham PrenaBelt
Sham PrenaBelt on First Sleep Test Night	Sham comparator	Participants will be randomized to treatment order: sham PrenaBelt on first night, then PrenaBelt 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 polysomnography equipment, which could bias the results. Receives: Device: PrenaBelt; Device: Sham PrenaBelt

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage (%) of Sleep Time Supine
Proportion of sleeping time spent in the supine position
Measured: 1 night (approximately 8 hours)

Secondary outcomes (28)

Total Sleep Time
This is a standard polysomnography measure of the amount of time the participant spent sleeping during the sleep test.
Measured: 1 night (approximately 8 hours)
Supine Sleep Time
The time (in minutes) spent sleeping in the supine position.
Measured: 1 night (approximately 8 hours)
Left-lateral Sleep Time
Time (in minutes) spent sleeping in the left-lateral position.
Measured: 1 night (approximately 8 hours)
Right-lateral Sleep Time
Time (in minutes) spent sleeping in the right-lateral position.
Measured: 1 night (approximately 8 hours)
Percentage Sleep Left
Percentage (%) of sleeping time in the left-lateral position.
Measured: 1 night (approximately 8 hours)
Percentage Sleep Right
Percentage (%) of sleeping time in the right-lateral position.
Measured: 1 night (approximately 8 hours)
Sleep Latency
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.
Measured: 1 night (approximately 8 hours)
Sleep Efficiency
This is a standard polysomnography measure of the percentage (%) of time the participant was asleep during the sleep test.
Measured: 1 night (approximately 8 hours)
Total Arousal Index
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.
Measured: 1 night (approximately 8 hours)
Spontaneous Arousal Index
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.
Measured: 1 night (approximately 8 hours)
Periodic Limb Movement Arousal Index
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.
Measured: 1 night (approximately 8 hours)
Respiratory Arousal Index
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 respiratory events. This is reported as an 'arousal index', which is an average of the number of arousals per hour.
Measured: 1 night (approximately 8 hours)
Percent Stage 1 Sleep
Percent (%) of total sleep time in sleep stage 1.
Measured: 1 night (approximately 8 hours)
Percent Stage 2 Sleep
Percent (%) of total sleep time in sleep stage 2.
Measured: 1 night (approximately 8 hours)
Percent Stage 3 Sleep
Percent (%) of total sleep time in sleep stage 3.
Measured: 1 night (approximately 8 hours)
Percent REM Sleep
Percent (%) of total sleep time in rapid eye movement (REM) sleep
Measured: 1 night (approximately 8 hours)
Apnea Hypopnea Index
Apnea hypopnea index (AHI) is a standard polysomnography measure to indicate the severity of sleep apnea. AHI is the average number of apnea and hypopnea events per hour. Will be reported as a total AHI in units of 'events per hour'.
Measured: 1 night (approximately 8 hours)
Respiratory Effort-Related Arousal Index
Respiratory Effort-Related Arousal (RERA) index is a standard polysomnography measure to indicate arousals from respiratory effort. Will be reported in units of 'arousals per hour'.
Measured: 1 night (approximately 8 hours)
Respiratory Disturbance Index (RDI)
This is a standard polysomnography measure. Like the AHI, RDI reports on respiratory events during sleep, but unlike the AHI, it also includes respiratory-effort related arousals (RERAs). RERAs are arousals from sleep that do not technically meet the definitions of apneas or hypopneas, but do disrupt sleep. Will be reported as a total RDI as well as RDI while supine and RDI while non-supine.
Measured: 1 night (approximately 8 hours)
Peripheral Blood Oxygen Saturation (SpO2)
SpO2 measured by fingertip pulse oximetry is a standard measure to indicate the oxygen saturation. Mean SpO2, Min SpO2, and Max SpO2 during Rapid Eye Movement (REM), and Non-REM (NREM) states.
Measured: 1 night (approximately 8 hours)
Number of Participants With Snoring
This is a standard polysomnography measure of the presence of snoring via nasal cannula (pressure transducer) and by objective report of the research assistant (real-time audio feed).
Measured: 1 night (approximately 8 hours)
PrenaBelt User Feedback Questionnaire - Satisfaction
Each participant will complete the PrenaBelt User Feedback Questionnaire.
On a scale of 1 to 10, participant's level of satisfaction with the PrenaBelt. Note:
1 = extremely dissatisfied 5-6 = acceptable 10 = extremely satisfied
Measured: 1 night (approximately 8 hours)
PrenaBelt User Feedback Questionnaire - Comfort
Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's level of comfort while wearing and sleeping with the PrenaBelt. Note:
1 = extremely uncomfortable 5-6 = acceptable 10 = extremely comfortable
Measured: 1 night (approximately 8 hours)
PrenaBelt User Feedback Questionnaire - Intention to Use
Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's intention to use the PrenaBelt during a subsequent pregnancy if it was available to her.
Note:
1 = participant would never use it again 5-6 = participant would consider using it again 10 = participant would certainly use it again
Measured: 1 night (approximately 8 hours)
Sleep Onset Position
To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the sleep onset position (left, supine, right) per the participant's self report and is compared with the sleep onset position (left, supine, right) per the polysomnography data.
Measured: 1 night (approximately 8 hours)
Waking Position
To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the participant's waking position (left, supine, right, prone) per the participant's self report and is compared with the waking position (left, supine, right, prone) per the polysomnography data.
Measured: 1 night (approximately 8 hours)
Number of Position Changes
To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the number of times the participant changed body position (e.g., supine to left side) per the participant's self report and is compared with the number of times the participant changed body position per the polysomnography data.
Measured: 1 night (approximately 8 hours)
Percentage of Total Sleep Time in Each Position
To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the percentage (%) of total sleep time in each position (left, supine, right, prone) per the participant's self report and is compared with the percentage (%) of total sleep time in each position (left, supine, right, prone) per the polysomnography data.
Measured: 1 night (approximately 8 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201628 Jan 2017

First posted4 Mar 2015 (estimated)
Study start15 Mar 2016
Primary completion28 Jan 2017
Study completion28 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for SleepStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02377817
Sponsor's protocol ID: GCC-S7-0629-01-10-HAL
Status last verified: Mar 2020
First submitted: 17 Feb 2015
Last updated: 2 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23507553
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.
PubMed 21673002
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.
PubMed 25568999
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.
PubMed 24885461
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.
PubMed 24731396
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.
PubMed 24661447
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.
PubMed 30158217

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modifying Maternal Sleep Position in the Third Trimester of Pregnancy With Positional Therapy: A Randomized Pilot Trial
ClinicalTrials.gov ID: NCT02377817
Acronym / sponsor ID: GCC-S7-0629-01-10-HAL
Conditions: Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Very Low Birth Weight
Keywords: positional therapy, tennis ball technique, sleep in pregnancy, supine, polysomnography, sleep position, supine position
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Allan KemberUniversity, hospital or other
Collaborators: Grand Challenges Canada, Innovative Canadians for Change, Global Innovations for Reproductive Health and Life, Kaishin Chu Design, Nova Scotia Health Authority, University of Michigan, Harvard University
Study start: 15 Mar 2016 (actual)
Primary completion: 28 Jan 2017 (actual)
Study completion: 28 Jan 2017 (actual)
First posted: 4 Mar 2015 (estimated)
Results: Posted 2 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Two nights: one night with a positional therapy (PT) device and one night with sham-PT device to determine treatment effect on outcomes.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PrenaBelt on First Sleep Test Night	Experimental	Device: PrenaBelt, Device: Sham PrenaBeltParticipants will be randomized to treatment order: sham PrenaBelt on first night, then PrenaBelt 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 polysomnography equipment, which could bias the results.
Sham PrenaBelt on First Sleep Test Night	Sham comparator	Device: PrenaBelt, Device: Sham PrenaBeltParticipants will be randomized to treatment order: sham PrenaBelt on first night, then PrenaBelt 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 polysomnography equipment, which could bias the results.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrenaBeltThe PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. PT is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition. The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back and right side of the user when she lies on her back or right side, respectively, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back or right side.	Device	PrenaBelt on First Sleep Test Night, Sham PrenaBelt on First Sleep Test Night
Sham PrenaBeltThe Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.	Device	PrenaBelt on First Sleep Test Night, Sham PrenaBelt on First Sleep Test Night

Primary outcome

Percentage (%) of Sleep Time Supine
Time frame: 1 night (approximately 8 hours)
Proportion of sleeping time spent in the supine position

28 secondary outcomes

Total Sleep Time
Time frame: 1 night (approximately 8 hours)
Supine Sleep Time
Time frame: 1 night (approximately 8 hours)
Left-lateral Sleep Time
Time frame: 1 night (approximately 8 hours)
Right-lateral Sleep Time
Time frame: 1 night (approximately 8 hours)
Percentage Sleep Left
Time frame: 1 night (approximately 8 hours)
Percentage Sleep Right
Time frame: 1 night (approximately 8 hours)
Sleep Latency
Time frame: 1 night (approximately 8 hours)
Sleep Efficiency
Time frame: 1 night (approximately 8 hours)
Total Arousal Index
Time frame: 1 night (approximately 8 hours)
Spontaneous Arousal Index
Time frame: 1 night (approximately 8 hours)
Periodic Limb Movement Arousal Index
Time frame: 1 night (approximately 8 hours)
Respiratory Arousal Index
Time frame: 1 night (approximately 8 hours)
Percent Stage 1 Sleep
Time frame: 1 night (approximately 8 hours)
Percent Stage 2 Sleep
Time frame: 1 night (approximately 8 hours)
Percent Stage 3 Sleep
Time frame: 1 night (approximately 8 hours)
Percent REM Sleep
Time frame: 1 night (approximately 8 hours)
Apnea Hypopnea Index
Time frame: 1 night (approximately 8 hours)
Respiratory Effort-Related Arousal Index
Time frame: 1 night (approximately 8 hours)
Respiratory Disturbance Index (RDI)
Time frame: 1 night (approximately 8 hours)
Peripheral Blood Oxygen Saturation (SpO2)
Time frame: 1 night (approximately 8 hours)
Number of Participants With Snoring
Time frame: 1 night (approximately 8 hours)
PrenaBelt User Feedback Questionnaire - Satisfaction
Time frame: 1 night (approximately 8 hours)
PrenaBelt User Feedback Questionnaire - Comfort
Time frame: 1 night (approximately 8 hours)
PrenaBelt User Feedback Questionnaire - Intention to Use
Time frame: 1 night (approximately 8 hours)
Sleep Onset Position
Time frame: 1 night (approximately 8 hours)
Waking Position
Time frame: 1 night (approximately 8 hours)
Number of Position Changes
Time frame: 1 night (approximately 8 hours)
Percentage of Total Sleep Time in Each Position
Time frame: 1 night (approximately 8 hours)

Results and safety

Results posted to the registry on 2 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PrenaBelt on First Night, Sham PrenaBelt on Second Night	13	10
Sham PrenaBelt on First Night, PrenaBelt on Second Night	10	10

Primary outcome: Percentage (%) of Sleep Time Supine

Time frame: 1 night (approximately 8 hours). Median (Inter-Quartile Range). Unit: percentage of sleep time (%)

Measure	PrenaBelt Night n = 20	Sham PrenaBelt Night n = 20
Value	3.5 (0.0 to 16.6)	16.4 (3.5 to 25.3)

Population analysed: Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants completed their polysomnography studies from April 8 2016 through January 27 2017. Each participant that finished the study completed two full nights (7pm to 7am) in the polysomnography laboratory.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PrenaBelt on First Night, Sham PrenaBelt on Second Night	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Sham PrenaBelt on First Night, PrenaBelt on Second Night	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Performed in a controlled sleep laboratory setting over two nights; therefore, caution should be taken when extrapolating the results to the home setting and across the third trimester. Due to the small sample, may have been under-powered.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23507553Owusu 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.
Background: PubMed 21673002Stacey 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.
Background: PubMed 25568999Gordon 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.
Background: PubMed 24885461Platts 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.
Background: PubMed 24731396Warland 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.
Background: PubMed 24661447O'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.
Derived from this study: PubMed 30158217Kember 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.
Allan Kember's (Project Lead, Project Principal Investigator) blog - Project UpdatesLink provided by the sponsor.
Grand Challenges Canada - News ReleaseLink provided by the sponsor.
Global Innovations for Reproductive Health and LifeLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heather Scott, MD FRCSC principal investigator

The IWK Health Centre

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PrenaBelt in people with Sleep and Pregnancy, run by Allan Kember at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage (%) of Sleep Time Supine (time frame: 1 night (approximately 8 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02377817, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.