Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
Study Details
Study Description
Brief Summary
The purpose of this study is to better understand how sleep apnea, a common sleep disorder in which a person has one or more pauses in breathing or shallow breaths while sleeping, may affect pregnancy and to determine the effect of Continuous Positive Airway Pressure (CPAP), a treatment that uses mild air pressure to keep the airways open during sleep, for pregnant women with sleep apnea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Emerging data support a link between sleep disordered breathing (SDB) and adverse pregnancy outcomes, particularly preeclampsia. Furthermore, SDB, which is characterized by intermittent nocturnal hypoxia-reoxygenation as well as sleep disruption, results in endothelial dysfunction and metabolic dysregulation, the same biological pathways that have been associated with adverse pregnancy outcomes. Obesity is a well-known risk factor for both adverse pregnancy outcomes and SDB, and has been associated with the same aforementioned biological aberrations. Therefore, obesity complicates the definition of a causal relationship between SDB and pregnancy outcomes. While some classic cardiovascular risk factors (prehypertension) are certainly relevant in pregnancy, there are also well-established risk factors that are unique to pregnancy (uterine vascular stiffness, placental angiogenic factors). The interplay between SDB, obesity and these unique cardiovascular risk factors remains undefined, and this proposal aims to address this knowledge gap. Without this data, our ability to understand how we can mitigate these risks through the use of therapeutic interventions for SDB, such as CPAP (continuous positive airway pressure), is compromised. To further address this knowledge gap, we will make use of the placenta's ability to accumulate evidence of damage over time and provide a record of maternal vascular health throughout gestation. Numerous placental lesions deriving from maternal vascular disease have been identified and can be readily detected on placental pathology. These lesions can provide a measure of the severity of hypoxic stress experienced by the fetus during gestation.
The investigators' central hypothesis is that SDB is an effect modifier that increases maternal cardiovascular risk and placental hypoxic injury in obese pregnant women, and that CPAP treatment during pregnancy will result in an improved cardiovascular risk and placental profile. To test this hypothesis the investigaotrs will identify a cohort of obese women both with and without SDB. The investigators will examine SDB's impact on maternal vascular stiffness (uterine artery Doppler), angiogenesis (pregnancy specific angiogenic factors e.g., sFLT-1) and metabolism (insulin resistance) across pregnancy (Aim 1). The investigators will perform a randomized controlled trial of autotitrating- CPAP verses sham-CPAP in pregnancy to examine the impact of CPAP treatment during pregnancy on cardiovascular risk (Aim 2) and will explore the interplay between SDB, CPAP and evidence of maternal vascular disease and chronic fetal hypoxia by evaluating the placental profile of obese women with and without SDB (Aim 3).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Obese, SDB negative No intervention, observational comparison group |
|
| Active Comparator: Obese, SDB postive, CPAP Therapeutic CPAP |
Device: 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).
Other Names:
|
| Sham Comparator: Obese, SDB postive, sham-CPAP Sham (non-therapeutic) CPAP |
Device: sham-CPAP
|
| Other: Obese, SDB postive, sleep hygiene Sleep hygiene information and local sleep resources |
Other: Sleep hygiene
Information about sleep apnea and healthy sleep. Information about local sleep resources
|
Outcome Measures
Primary Outcome Measures
- Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound [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.
- Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement [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.
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin [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)
- Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound [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.
- Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement [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.
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin [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)
Secondary Outcome Measures
- Placental Histology and Immunohistochemistry [After delivery (expected 37-40 weeks gestation)]
Other Outcome Measures
- Mean Arterial Blood Pressure (mmHg) Angiogenic Domain [early pregnancy (14-16 weeks gestation)]
- Pregnancy Outcome Data [At time of delivery (expected 37-40 weeks gestation)]
Preeclampsia, Gestational diabetes, Gestational age at delivery, Indication for delivery, Birthweight, Cord gases
- Mean Arterial Blood Pressure (mmHg) Angiogenic Domain [late pregnancy (28-32 weeks gestation)]
- Soluble Endoglin (sEng ,pg/mL)-Blood Measurement [early pregnancy (14-16 weeks gestation)]
Endoglin is a coreceptor for transforming growth factor beta-1 and beta-3 expressed on syncytiotrophoblasts
- Soluble Endoglin (sEng , pg/mL)-Blood Measurement [late pregnancy (28-32 weeks gestation)]
Endoglin is a coreceptor for transforming growth factor beta-1 and beta-3 expressed on syncytiotrophoblasts
Eligibility Criteria
Criteria
Inclusion Criteria:
-
women between 14 0/7 and 20 6/7 weeks gestation at the time of their initial PSG assessment.
-
Pregnancy and current BMI >=30
-
Self-reported frequent snoring (>=3x/week over past month) or self-reported non-snorer.
Exclusion Criteria:
-
diagnosis of pregestational diabetes.
-
self-report a history of sleep apena and who are using or were receommended by a physican to use a PAP device already
-
twins
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Magee-Womens Hospital of the UPMC | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Francesca Facco, MD
- National Heart, Lung, and Blood Institute (NHLBI)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Francesca Facco, MD, University of Pittsburgh
Study Documents (Full-Text)
More Information
Publications
None provided.- PRO13080159
- R01HL120354
- K12HD043441
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, Sleep Hygiene | Obese SDB CPAP Phase 2 |
|---|---|---|---|---|
| Arm/Group Description | 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). | Sham (non-therapeutic) CPAP sham-CPAP | Sleep hygiene information and local sleep resources Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources | Therapeutic CPAP |
| Period Title: Overall Study | ||||
| STARTED | 25 | 26 | 20 | 18 |
| COMPLETED | 24 | 26 | 20 | 16 |
| NOT COMPLETED | 1 | 0 | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sleep Hygiene | Obese, SDB Positive, CPAP Phase 2 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Sham (non-therapeutic) CPAP sham-CPAP | 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). | Sleep hygiene information and local sleep resources Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources | Therapeutic CPAP | Total of all reporting groups |
| Overall Participants | 26 | 25 | 20 | 18 | 89 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
26.4
(3.9)
|
28.4
(6.5)
|
32.0
(4.5)
|
32.6
(4.5)
|
29.6
(5.5)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
26
100%
|
25
100%
|
20
100%
|
18
100%
|
89
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
5%
|
0
0%
|
1
1.1%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
19
73.1%
|
16
64%
|
13
65%
|
9
50%
|
57
64%
|
| White |
5
19.2%
|
9
36%
|
6
30%
|
9
50%
|
29
32.6%
|
| More than one race |
2
7.7%
|
0
0%
|
0
0%
|
0
0%
|
2
2.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound |
|---|---|
| Description | 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. |
| Time Frame | early pregnancy (14-16 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sleep Hygiene | Obese, SBD Positive, CPAP, Phase 2 |
|---|---|---|---|---|
| Arm/Group Description | Sham (non-therapeutic) CPAP sham-CPAP | 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). | Sleep hygiene information and local sleep resources Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources | Therapeutic CPAP |
| Measure Participants | 26 | 25 | 20 | 18 |
| Mean (Standard Deviation) [Mean PI] |
1.0
(0.3)
|
1.0
(0.3)
|
1.0
(0.3)
|
1.0
(0.3)
|
| Title | Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement |
|---|---|
| Description | 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. |
| Time Frame | early pregnancy (14-16 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sleep Hygiene | Obese, SBD Positive, CPAP, Phase 2 |
|---|---|---|---|---|
| Arm/Group Description | Sham (non-therapeutic) CPAP sham-CPAP | 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). | Sleep hygiene information and local sleep resources Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources | Therapeutic CPAP |
| Measure Participants | 26 | 25 | 20 | 18 |
| Mean (Standard Deviation) [Ratio] |
53.8
(29.1)
|
65.1
(45.8)
|
87.0
(69.1)
|
88.3
(45.0)
|
| Title | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin |
|---|---|
| Description | 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) |
| Time Frame | early pregnancy (14-16 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sleep Hygiene | Obese, SBD Positive, CPAP, Phase 2 |
|---|---|---|---|---|
| Arm/Group Description | Sham (non-therapeutic) CPAP sham-CPAP | 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). | Sleep hygiene information and local sleep resources Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources | Therapeutic CPAP |
| Measure Participants | 26 | 25 | 20 | 18 |
| Mean (Standard Deviation) [HOMA-IR score] |
4.5
(3.5)
|
4.6
(6.4)
|
3.9
(2.2)
|
4.2
(3.0)
|
| Title | Uterine Artery Doppler Mean Pulsatility Index -by Ultrasound |
|---|---|
| Description | 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. |
| Time Frame | late pregnancy (28-32 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sleep Hygiene | Obese, SBD Positive, CPAP, Phase 2 |
|---|---|---|---|---|
| Arm/Group Description | Sham (non-therapeutic) CPAP sham-CPAP | 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). | Sleep hygiene information and local sleep resources Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources | Therapeutic CPAP |
| Measure Participants | 26 | 24 | 20 | 16 |
| Mean (Standard Deviation) [Mean PI] |
0.9
(0.2)
|
0.8
(0.3)
|
0.8
(0.2)
|
0.7
(0.1)
|
| Title | Soluble FMS-like Tyrosine Kinase 1 (sFlt-1)/ Placental Growth Factor (PlGF) Ratio-blood Measurement |
|---|---|
| Description | 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. |
| Time Frame | late pregnancy (28-32 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sleep Hygiene | Obese, SBD Positive, CPAP, Phase 2 |
|---|---|---|---|---|
| Arm/Group Description | Sham (non-therapeutic) CPAP sham-CPAP | 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). | Sleep hygiene information and local sleep resources Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources | Therapeutic CPAP |
| Measure Participants | 26 | 25 | 20 | 18 |
| Mean (Standard Deviation) [Ratio] |
30.5
(28.9)
|
26.0
(18.3)
|
38.3
(34.7)
|
45.9
(57.3)
|
| Title | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-Blood Measurement of Glucose and Insulin |
|---|---|
| Description | 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) |
| Time Frame | late pregnancy (28-32 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sleep Hygiene | Obese, SBD Positive, CPAP, Phase 2 |
|---|---|---|---|---|
| Arm/Group Description | Sham (non-therapeutic) CPAP sham-CPAP | 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). | Sleep hygiene information and local sleep resources Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources | Therapeutic CPAP |
| Measure Participants | 26 | 25 | 20 | 18 |
| Mean (Standard Deviation) [HOMA-IR score] |
6.3
(10.7)
|
3.7
(3.6)
|
3.6
(1.8)
|
4.6
(6.3)
|
| Title | Placental Histology and Immunohistochemistry |
|---|---|
| Description | |
| Time Frame | After delivery (expected 37-40 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Mean Arterial Blood Pressure (mmHg) Angiogenic Domain |
|---|---|
| Description | |
| Time Frame | early pregnancy (14-16 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Pregnancy Outcome Data |
|---|---|
| Description | Preeclampsia, Gestational diabetes, Gestational age at delivery, Indication for delivery, Birthweight, Cord gases |
| Time Frame | At time of delivery (expected 37-40 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Mean Arterial Blood Pressure (mmHg) Angiogenic Domain |
|---|---|
| Description | |
| Time Frame | late pregnancy (28-32 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Soluble Endoglin (sEng ,pg/mL)-Blood Measurement |
|---|---|
| Description | Endoglin is a coreceptor for transforming growth factor beta-1 and beta-3 expressed on syncytiotrophoblasts |
| Time Frame | early pregnancy (14-16 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Soluble Endoglin (sEng , pg/mL)-Blood Measurement |
|---|---|
| Description | Endoglin is a coreceptor for transforming growth factor beta-1 and beta-3 expressed on syncytiotrophoblasts |
| Time Frame | late pregnancy (28-32 weeks gestation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | From enrollment to 6 weeks post partum, an average of 1 year | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, Sleep Hygiene | Obese, SBD Positive, CPAP, Phase 2 | ||||
| Arm/Group Description | 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). | Sham (non-therapeutic) CPAP sham-CPAP | Sleep hygiene information and local sleep resources Sleep hygiene: Information about sleep apnea and healthy sleep. Information about local sleep resources | Therapeutic CPAP | ||||
All Cause Mortality |
||||||||
| Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, Sleep Hygiene | Obese, SBD Positive, CPAP, Phase 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/26 (0%) | 0/20 (0%) | 0/18 (0%) | ||||
Serious Adverse Events |
||||||||
| Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, Sleep Hygiene | Obese, SBD Positive, CPAP, Phase 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/25 (4%) | 0/26 (0%) | 0/20 (0%) | 1/18 (5.6%) | ||||
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Maternal ICU admission | 0/25 (0%) | 0/26 (0%) | 0/20 (0%) | 1/18 (5.6%) | ||||
| Fetal Demise | 1/25 (4%) | 0/26 (0%) | 0/20 (0%) | 0/18 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Obese, SDB Postive, CPAP, Phase 1 | Obese, SDB Postive, Sham-CPAP | Obese, SDB Postive, Sleep Hygiene | Obese, SBD Positive, CPAP, Phase 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 3/26 (11.5%) | 0/20 (0%) | 1/18 (5.6%) | ||||
| Cardiac disorders | ||||||||
| EKG abnormality | 0/25 (0%) | 1/26 (3.8%) | 0/20 (0%) | 0/18 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| CPAP complication | 0/25 (0%) | 1/26 (3.8%) | 0/20 (0%) | 1/18 (5.6%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Rash | 0/25 (0%) | 1/26 (3.8%) | 0/20 (0%) | 0/18 (0%) | ||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Francesca Facco |
|---|---|
| Organization | University of Pittsburgh |
| Phone | 412-641-1220 |
| Faccof@upmc.edu |
- PRO13080159
- R01HL120354
- K12HD043441