Trial Outcomes & Findings for Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP) (NCT NCT02086448)
NCT ID: NCT02086448
Last Updated: 2023-03-22
Results Overview
The uterine artery was located using color doppler imaging by placing the ultrasound probe in the right or left iliac fossa in the sagittal plane. The uterine artery was then identified where it crosses the external iliac artery. Doppler waveform was obtained using a sampling gate encompassing the width of the main uterine artery at an angle of insonation of \<30 degrees if possible. The PI was calculated using the formula: maximum-minimum velocity/mean velocity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
242 participants
Primary outcome timeframe
early pregnancy (14-16 weeks gestation)
Results posted on
2023-03-22
Participant Flow
A total of 452 individuals were screened and 355 participants consented for this study . Prior to or during the inital study visit, 113 individuals withdrew or were withdrawn from the study. 242 participants completed visit 1 (14 0/7-20 6/7 weeks gestation, mean gestational age 18.1 ± 2.0 weeks), of whom 89 (37%) had an AHI between 5 and 50 and therefore were eligible for randomization.
Participant milestones
| Measure |
Obese, SDB Postive, CPAP, Phase 1
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sham-CPAP
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, Sleep Hygiene
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese SDB CPAP Phase 2
Therapeutic CPAP
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
20
|
18
|
|
Overall Study
COMPLETED
|
24
|
26
|
20
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Obese, SDB Postive, CPAP, Phase 1
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sham-CPAP
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, Sleep Hygiene
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese SDB CPAP Phase 2
Therapeutic CPAP
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
Baseline Characteristics
Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
Baseline characteristics by cohort
| Measure |
Obese, SDB Postive, Sham-CPAP
n=26 Participants
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, CPAP, Phase 1
n=25 Participants
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sleep Hygiene
n=20 Participants
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese, SDB Positive, CPAP Phase 2
n=18 Participants
Therapeutic CPAP
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
28.4 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
32.0 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
29.6 years
STANDARD_DEVIATION 5.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: early pregnancy (14-16 weeks gestation)The uterine artery was located using color doppler imaging by placing the ultrasound probe in the right or left iliac fossa in the sagittal plane. The uterine artery was then identified where it crosses the external iliac artery. Doppler waveform was obtained using a sampling gate encompassing the width of the main uterine artery at an angle of insonation of \<30 degrees if possible. The PI was calculated using the formula: maximum-minimum velocity/mean velocity.
Outcome measures
| Measure |
Obese, SDB Postive, Sham-CPAP
n=26 Participants
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, CPAP, Phase 1
n=25 Participants
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sleep Hygiene
n=20 Participants
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese, SBD Positive, CPAP, Phase 2
n=18 Participants
Therapeutic CPAP
|
|---|---|---|---|---|
|
Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound
|
1.0 Mean PI
Standard Deviation 0.3
|
1.0 Mean PI
Standard Deviation 0.3
|
1.0 Mean PI
Standard Deviation 0.3
|
1.0 Mean PI
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: early pregnancy (14-16 weeks gestation)sFlt-1 is a splice variant of vascular endothelial growth receptor (VEGF) with antiangiogenic properties that is upregulated in preeclampsia. PlGF is an angiogenic cytokine that is highly expressed in the placenta. Low levels have been associated with preeclampsia.
Outcome measures
| Measure |
Obese, SDB Postive, Sham-CPAP
n=26 Participants
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, CPAP, Phase 1
n=25 Participants
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sleep Hygiene
n=20 Participants
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese, SBD Positive, CPAP, Phase 2
n=18 Participants
Therapeutic CPAP
|
|---|---|---|---|---|
|
Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement
|
53.8 Ratio
Standard Deviation 29.1
|
65.1 Ratio
Standard Deviation 45.8
|
87.0 Ratio
Standard Deviation 69.1
|
88.3 Ratio
Standard Deviation 45.0
|
PRIMARY outcome
Timeframe: early pregnancy (14-16 weeks gestation)Insulin resistance was calculated using the homeostatic model assessment for insulin resistance (HOMA-IR, fasting insulin (µU/mL) x fasting glucose (mmol/L) /22.5)
Outcome measures
| Measure |
Obese, SDB Postive, Sham-CPAP
n=26 Participants
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, CPAP, Phase 1
n=25 Participants
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sleep Hygiene
n=20 Participants
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese, SBD Positive, CPAP, Phase 2
n=18 Participants
Therapeutic CPAP
|
|---|---|---|---|---|
|
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin
|
4.5 HOMA-IR score
Standard Deviation 3.5
|
4.6 HOMA-IR score
Standard Deviation 6.4
|
3.9 HOMA-IR score
Standard Deviation 2.2
|
4.2 HOMA-IR score
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: late pregnancy (28-32 weeks gestation)The uterine artery was located using color doppler imaging by placing the ultrasound probe in the right or left iliac fossa in the sagittal plane. The uterine artery was then identified where it crosses the external iliac artery. Doppler waveform was obtained using a sampling gate encompassing the width of the main uterine artery at an angle of insonation of \<30 degrees if possible. The PI was calculated using the formula: maximum-minimum velocity/mean velocity.
Outcome measures
| Measure |
Obese, SDB Postive, Sham-CPAP
n=26 Participants
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, CPAP, Phase 1
n=24 Participants
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sleep Hygiene
n=20 Participants
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese, SBD Positive, CPAP, Phase 2
n=16 Participants
Therapeutic CPAP
|
|---|---|---|---|---|
|
Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound
|
0.9 Mean PI
Standard Deviation 0.2
|
0.8 Mean PI
Standard Deviation 0.3
|
0.8 Mean PI
Standard Deviation 0.2
|
0.7 Mean PI
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: late pregnancy (28-32 weeks gestation)sFlt-1 is a splice variant of vascular endothelial growth receptor (VEGF) with antiangiogenic properties that is upregulated in preeclampsia. PlGF is an angiogenic cytokine that is highly expressed in the placenta. Low levels have been associated with preeclampsia.
Outcome measures
| Measure |
Obese, SDB Postive, Sham-CPAP
n=26 Participants
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, CPAP, Phase 1
n=25 Participants
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sleep Hygiene
n=20 Participants
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese, SBD Positive, CPAP, Phase 2
n=18 Participants
Therapeutic CPAP
|
|---|---|---|---|---|
|
Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement
|
30.5 Ratio
Standard Deviation 28.9
|
26.0 Ratio
Standard Deviation 18.3
|
38.3 Ratio
Standard Deviation 34.7
|
45.9 Ratio
Standard Deviation 57.3
|
PRIMARY outcome
Timeframe: late pregnancy (28-32 weeks gestation)Insulin resistance was calculated using the homeostatic model assessment for insulin resistance (HOMA-IR, fasting insulin (µU/mL) x fasting glucose (mmol/L) /22.5)
Outcome measures
| Measure |
Obese, SDB Postive, Sham-CPAP
n=26 Participants
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, CPAP, Phase 1
n=25 Participants
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sleep Hygiene
n=20 Participants
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese, SBD Positive, CPAP, Phase 2
n=18 Participants
Therapeutic CPAP
|
|---|---|---|---|---|
|
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin
|
6.3 HOMA-IR score
Standard Deviation 10.7
|
3.7 HOMA-IR score
Standard Deviation 3.6
|
3.6 HOMA-IR score
Standard Deviation 1.8
|
4.6 HOMA-IR score
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: After delivery (expected 37-40 weeks gestation)Population: Placental collection and analysis was not performed due to inadequate staffing and personnel issues
placental histology and immunohistochemistry
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: early pregnancy (14-16 weeks gestation)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of delivery (expected 37-40 weeks gestation)Preeclampsia, Gestational diabetes, Gestational age at delivery, Indication for delivery, Birthweight, Cord gases
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: late pregnancy (28-32 weeks gestation)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: early pregnancy (14-16 weeks gestation)Endoglin is a coreceptor for transforming growth factor beta-1 and beta-3 expressed on syncytiotrophoblasts
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: late pregnancy (28-32 weeks gestation)Endoglin is a coreceptor for transforming growth factor beta-1 and beta-3 expressed on syncytiotrophoblasts
Outcome measures
Outcome data not reported
Adverse Events
Obese, SDB Postive, CPAP, Phase 1
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese, SDB Postive, Sham-CPAP
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Obese, SDB Postive, Sleep Hygiene
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese, SBD Positive, CPAP, Phase 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Obese, SDB Postive, CPAP, Phase 1
n=25 participants at risk
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sham-CPAP
n=26 participants at risk
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, Sleep Hygiene
n=20 participants at risk
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese, SBD Positive, CPAP, Phase 2
n=18 participants at risk
Therapeutic CPAP
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Maternal ICU admission
|
0.00%
0/25 • From enrollment to 6 weeks post partum, an average of 1 year
|
0.00%
0/26 • From enrollment to 6 weeks post partum, an average of 1 year
|
0.00%
0/20 • From enrollment to 6 weeks post partum, an average of 1 year
|
5.6%
1/18 • From enrollment to 6 weeks post partum, an average of 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Fetal Demise
|
4.0%
1/25 • From enrollment to 6 weeks post partum, an average of 1 year
|
0.00%
0/26 • From enrollment to 6 weeks post partum, an average of 1 year
|
0.00%
0/20 • From enrollment to 6 weeks post partum, an average of 1 year
|
0.00%
0/18 • From enrollment to 6 weeks post partum, an average of 1 year
|
Other adverse events
| Measure |
Obese, SDB Postive, CPAP, Phase 1
n=25 participants at risk
Therapeutic CPAP
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
|
Obese, SDB Postive, Sham-CPAP
n=26 participants at risk
Sham (non-therapeutic) CPAP
sham-CPAP
|
Obese, SDB Postive, Sleep Hygiene
n=20 participants at risk
Sleep hygiene information and local sleep resources
Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Obese, SBD Positive, CPAP, Phase 2
n=18 participants at risk
Therapeutic CPAP
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
CPAP complication
|
0.00%
0/25 • From enrollment to 6 weeks post partum, an average of 1 year
|
3.8%
1/26 • From enrollment to 6 weeks post partum, an average of 1 year
|
0.00%
0/20 • From enrollment to 6 weeks post partum, an average of 1 year
|
5.6%
1/18 • From enrollment to 6 weeks post partum, an average of 1 year
|
|
Cardiac disorders
EKG abnormality
|
0.00%
0/25 • From enrollment to 6 weeks post partum, an average of 1 year
|
3.8%
1/26 • From enrollment to 6 weeks post partum, an average of 1 year
|
0.00%
0/20 • From enrollment to 6 weeks post partum, an average of 1 year
|
0.00%
0/18 • From enrollment to 6 weeks post partum, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • From enrollment to 6 weeks post partum, an average of 1 year
|
3.8%
1/26 • From enrollment to 6 weeks post partum, an average of 1 year
|
0.00%
0/20 • From enrollment to 6 weeks post partum, an average of 1 year
|
0.00%
0/18 • From enrollment to 6 weeks post partum, an average of 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place