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UniSA BackOff! Study: Adelaide PrenaBelt Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437407
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : December 16, 2020
Sponsor:
Collaborator:
University of South Australia
Information provided by (Responsible Party):
Shiphrah Biomedical Inc.

Brief Summary:

Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty times increased risk of death in the first year of life and high rates of short- and long-term illnesses. Sleeping on one's back during pregnancy has recently emerged as a potential risk factor for LBW and SB in the medical literature. In high-income countries, SB rates have mostly remained the same in the past two decades and targeting modifiable risk factors could help reduce the number of SB and LBW in the population.

When a pregnant woman sleeps on her back, her body position compresses underlying blood vessels and reduces blood flow to the developing baby. This body position could cause unpleasant symptoms for the mother and result in LBW or SB of her baby. Lying on her side or with a slight lateral tilt helps relieve this compression. One way to keep people off their back while sleeping is by using positional therapy (PT). It is a simple, safe, inexpensive and effective intervention for preventing people who snore or people who's breathing pauses during sleep from sleeping on their back. Reducing the amount of time pregnant women sleep on their back could help reduce SB and LBW rates. The investigators developed a PT device (PrenaBelt) and tested it in three clinical trials, which demonstrated that it significantly decreases the number of time women spend sleeping on their back. Using feedback from our previous research, the investigators developed five additional devices that will be tested in this study.

The purpose of this study is to evaluate the new PrenaBelt (PB2) prototypes' ability to reduce the amount of time pregnant women sleep on their backs in the third trimester of pregnancy, validate the Ajuvia Sleep Monitor, and collect feedback on the devices.

Demonstrating that the sleeping position of pregnant women can be modified through the use of a simple, inexpensive PT intervention may be one of the keys to achieving significant reductions in LBW and late SB rates in Australia and worldwide.


Condition or disease Intervention/treatment Phase
Stillbirth Infant, Low Birth Weight Infant, Very Low Birth Weight Sleep-Disordered Breathing Infant, Small for Gestational Age Fetal Hypoxia Pregnancy Complications Fetal Growth Retardation Device: PB2-1 prototype Device: PB2-2 prototype Device: PB2-3 prototype Device: PB2-4 prototype Device: PB2-5 prototype Device: Ajuvia-Active Device: Ajuvia-Passive Not Applicable

Detailed Description:

The ability of the PB2 prototypes to reduce the amount of time pregnant women spend sleeping on their backs at night in the home setting in the third trimester of pregnancy will be evaluated via a consecutive, six-night, in-home, controlled, cross-over sleep study in third trimester pregnant women where the Ajuvia Sleep Monitor is validated against infrared video on the first night.

Six nights: the first night is a control night with infrared video recording where only the Ajuvia is worn in passive mode to collect data on the participant's body position and is followed by five nights with the five different prototypes.

Randomization: The order in which the different devices will be worn on the second night through fourth night, inclusive, will be determined by simple randomization. This will minimize the potential impact of changes to sleep across the nights resulting from familiarization with the equipment as the sleep tests proceed through the five non-control nights, which could bias the results. For logistical reasons, the sixth night is non-randomized and will include the Ajuvia in 'active' mode Cross-over: After the first night, on each of the subsequent four nights, the participants will "cross over" to a different PB2 device (depending on their randomization order) and "cross over" to the Ajuvia in 'active' mode on the sixth night to allow each participant to act as her own control for comparison of treatment effect on outcomes.

In home: conducting this study in the home setting will allow for a more accurate representation of sleep patterns as the participants will be in the comfort of their own bed.

Sleep test: The maternal pelvis position will be recorded while the participants are sleeping using the Ajuvia device. Going to bed- and wake-times, as well as experience with each device will be recorded daily in a sleep diary.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A consecutive, six-night, in-home, controlled, cross-over sleep study in third-trimester pregnant women to validate the ability of the PB2 and Ajuvia devices to reduce the amount of time pregnant women spend sleeping on their backs at night in the home setting in the third trimester of pregnancy
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: UniSA BackOff! Study: A Randomized, Controlled, Five-way, Cross-over Trial to Evaluate the Effect of a Positional Therapy Device on Maternal Sleeping Position in the Third Trimester of Pregnancy
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control
The first night will be a control night with infrared video recording where only the Ajuvia sleep monitor is worn in passive mode so that each participant can act as her own control for comparison of treatment effect on outcomes.
Device: Ajuvia-Passive
Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.

Experimental: PB2-1
During this night, the PB2-1 prototype will be worn with the Ajuvia in passive mode.
Device: PB2-1 prototype
PB2-1 prototype is a belt-like wearable device similar to the original PrenaBelt designed for pregnant women that permits supine positioning of the pelvis but, when in this position, provides subtle pressure points to the user's body and thereby activates the body's natural mechanism to reposition itself to relieve discomfort. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

Device: Ajuvia-Passive
Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.

Experimental: PB2-2
During this night, the PB2-2 prototype will be worn with the Ajuvia in passive mode.
Device: PB2-2 prototype
PB2-2 prototype is a belt-like wearable device designed for pregnant women. When placed on the woman's back, this device prevents the pelvis from achieving a supine orientation by maintaining at least fifteen degrees of right or left lateral pelvic tilt. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

Device: Ajuvia-Passive
Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.

Experimental: PB2-3
During this night, the PB2-3 prototype will be worn with the Ajuvia in passive mode.
Device: PB2-3 prototype
PB2-3 prototype is a belt-like wearable device designed for pregnant women. When placed on the woman's back, this device prevents the pelvis from achieving a supine orientation by maintaining at least fifteen degrees of right or left lateral pelvic tilt. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

Device: Ajuvia-Passive
Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.

Experimental: PB2-4
During this night, the PB2-4 prototype will be worn with the Ajuvia in passive mode.
Device: PB2-4 prototype
PB2-4 prototype is a belt-like wearable device designed for pregnant women that prevents the user from achieving a supine position as the device allows right and left lateral pelvic tilt but prevents the user's pelvis from settling supine due to virtue of its design. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

Device: Ajuvia-Passive
Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.

Experimental: PB2-5
During this night, the PB2-5 prototype will be worn with the Ajuvia in active mode.
Device: PB2-5 prototype
PB2-5 prototype is a belt-like wearable device designed for pregnant women that does not provide positional therapy. It can be worn anytime as a maternity support belt.

Device: Ajuvia-Active
Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the active mode, it alerts the woman when her pelvis is in the supine position through a gentle vibratory alarm.




Primary Outcome Measures :
  1. Sensitivity of Ajuvia for supine position [ Time Frame: 1 night (approximately 8 hours) ]
    The sensitivity(%) of the Ajuvia in determining the pelvic supine position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  2. Specificity of Ajuvia for supine position [ Time Frame: 1 night (approximately 8 hours) ]
    The specificity(%) of the Ajuvia in determining the pelvic supine position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  3. Sensitivity of Ajuvia for prone position [ Time Frame: 1 night (approximately 8 hours) ]
    The sensitivity(%) of the Ajuvia in determining the pelvic prone position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  4. Specificity of Ajuvia for prone position [ Time Frame: 1 night (approximately 8 hours) ]
    The specificity(%) of the Ajuvia in determining the pelvic prone position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  5. Sensitivity of Ajuvia for left tilt position [ Time Frame: 1 night (approximately 8 hours) ]
    The sensitivity(%) of the Ajuvia in determining the left pelvic tilt position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  6. Specificity of Ajuvia for left tilt position [ Time Frame: 1 night (approximately 8 hours) ]
    The specificity(%) of the Ajuvia in determining the left pelvic tilt position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  7. Sensitivity of Ajuvia for left lateral position [ Time Frame: 1 night (approximately 8 hours) ]
    The sensitivity(%) of the Ajuvia in determining the left lateral pelvic position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  8. Specificity of Ajuvia for left lateral position [ Time Frame: 1 night (approximately 8 hours) ]
    The specificity(%) of the Ajuvia in determining the left lateral pelvic position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  9. Sensitivity of Ajuvia for right tilt position [ Time Frame: 1 night (approximately 8 hours) ]
    The sensitivity(%) of the Ajuvia in determining the right pelvic tilt position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  10. Specificity of Ajuvia for right tilt position [ Time Frame: 1 night (approximately 8 hours) ]
    The specificity(%) of the Ajuvia in determining the right pelvic tilt position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  11. Sensitivity of Ajuvia for right lateral position [ Time Frame: 1 night (approximately 8 hours) ]
    The sensitivity(%) of the Ajuvia in determining the right lateral pelvic position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  12. Specificity of Ajuvia for right lateral position [ Time Frame: 1 night (approximately 8 hours) ]
    The specificity(%) of the Ajuvia in determining the right lateral pelvic position during night sleep against the gold-standard of position as determined by review of infrared video will be calculated using a two-by-two contingency table.

  13. Supine Sleep Time - Control [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the supine position with Ajuvia in passive mode

  14. Supine Sleep Time - PB2-1 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the supine position with PB2-1 and Ajuvia in passive mode

  15. Supine Sleep Time - PB2-2 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the supine position with PB2-2 and Ajuvia in passive mode

  16. Supine Sleep Time - PB2-3 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the supine position with PB2-3 and Ajuvia in passive mode

  17. Supine Sleep Time - PB2-4 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the supine position with PB2-4 and Ajuvia in passive mode

  18. Supine Sleep Time - PB2-5 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the supine position with PB2-5 and Ajuvia in active mode

  19. Prone Sleep Time - Control [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the prone position with Ajuvia in passive mode

  20. Prone Sleep Time - PB2-1 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the prone position with PB2-1 and Ajuvia in passive mode

  21. Prone Sleep Time - PB2-2 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the prone position with PB2-2 and Ajuvia in passive mode

  22. Prone Sleep Time - PB2-3 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the prone position with PB2-3 and Ajuvia in passive mode

  23. Prone Sleep Time - PB2-4 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the prone position with PB2-4 and Ajuvia in passive mode

  24. Prone Sleep Time - PB2-5 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the prone position with PB2-5 and Ajuvia in active mode

  25. Left-tilt Sleep Time - Control [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left pelvic tilt position with Ajuvia in passive mode

  26. Left-tilt Sleep Time - PB2-1 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-1 and Ajuvia in passive mode

  27. Left-tilt Sleep Time - PB2-2 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-2 and Ajuvia in passive mode

  28. Left-tilt Sleep Time - PB2-3 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-3 and Ajuvia in passive mode

  29. Left-tilt Sleep Time - PB2-4 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-4 and Ajuvia in passive mode

  30. Left-tilt Sleep Time - PB2-5 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left pelvic tilt position with PB2-5 and Ajuvia in active mode

  31. Left-lateral Sleep Time - Control [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left lateral position with Ajuvia in passive mode

  32. Left-lateral Sleep Time - PB2-1 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left lateral position with PB2-1 and Ajuvia in passive mode

  33. Left-lateral Sleep Time - PB2-2 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left lateral position with PB2-2 and Ajuvia in passive mode

  34. Left-lateral Sleep Time - PB2-3 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left lateral position with PB2-3 and Ajuvia in passive mode

  35. Left-lateral Sleep Time - PB2-4 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left lateral position with PB2-4 and Ajuvia in passive mode

  36. Left-lateral Sleep Time - PB2-5 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the left-lateral position with PB2-5 and Ajuvia in active mode

  37. Right-tilt Sleep Time - Control [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right pelvic tilt position with Ajuvia in passive mode

  38. Right-tilt Sleep Time - PB2-1 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-1 and Ajuvia in passive mode

  39. Right-tilt Sleep Time - PB2-2 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-2 and Ajuvia in passive mode

  40. Right-tilt Sleep Time - PB2-3 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-3 and Ajuvia in passive mode

  41. Right-tilt Sleep Time - PB2-4 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-4 and Ajuvia in passive mode

  42. Right-tilt Sleep Time - PB2-5 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right pelvic tilt position with PB2-5 and Ajuvia in active mode

  43. Right-lateral Sleep Time - Control [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right lateral position with Ajuvia in passive mode

  44. Right-lateral Sleep Time - PB2-1 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right lateral position with PB2-1 and Ajuvia in passive mode

  45. Right-lateral Sleep Time - PB2-2 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right lateral position with PB2-2 and Ajuvia in passive mode

  46. Right-lateral Sleep Time - PB2-3 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right lateral position with PB2-3 and Ajuvia in passive mode

  47. Right-lateral Sleep Time - PB2-4 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right lateral position with PB2-4 and Ajuvia in passive mode

  48. Right-lateral Sleep Time - PB2-5 [ Time Frame: 1 night (approximately 8 hours) ]
    The time (in minutes) spent sleeping in the right lateral position with PB2-5 and Ajuvia in active mode



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥18 years old
  • low-risk singleton pregnancy
  • in the last trimester of pregnancy (at least 28 weeks + 0 days but not more than 36 weeks + 0 days of gestation)
  • access to and ability to use iPhone (for downloading and using Ajuvia app)
  • residing in the Greater Adelaide Area.

Exclusion Criteria:

  • musculoskeletal disorder that prevents sleeping supine or on a certain side (e.g., arthritic shoulder)
  • non-English speaking and reading

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437407


Contacts
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Contact: Allan Kember, MD 416-360-4000 allankember@gmail.com
Contact: Jesse Wells jessehwells@gmail.com

Locations
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Australia, South Australia
UniSA Clinical & Health Sciences Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Jane Warland       Jane.Warland@unisa.edu.au   
Sponsors and Collaborators
Shiphrah Biomedical Inc.
University of South Australia
Investigators
Layout table for investigator information
Principal Investigator: Jane Warland, PhD University of South Australia
Publications:

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Responsible Party: Shiphrah Biomedical Inc.
ClinicalTrials.gov Identifier: NCT04437407    
Other Study ID Numbers: 202902
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shiphrah Biomedical Inc.:
Pregnancy
Sleep
Maternal
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Pregnancy Complications
Stillbirth
Fetal Growth Retardation
Fetal Hypoxia
Body Weight
Hypoxia
Birth Weight
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Fetal Death
Death
Fetal Diseases
Growth Disorders