Obstructive Sleep Apnea
Conditions
Keywords
OSA, pregnancy, adverse pregnancy outcomes, continuous positive airway pressure, preeclampsia, gestational diabetes
Brief summary
Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again between 8 to 12 weeks postpartum.
Detailed description
Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for obstructive sleep apnea (OSA; defined as an apnea hypopnea index \[AHI\] ≥5 events/hour) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late = between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation). At 8 to 12 months postpartum subjects in both groups will complete a sleep study.
Interventions
DEVICECPAP
Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
OTHERPre-natal care
Standard Pre-Natal Care
Sponsors
United States Naval Medical Center, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. At least one of the following risk factors for OSA: prepregnancy BMI ≥ 30kg/m2, chronic hypertension, pregestational diabetes, twin gestation, or a history of prior pregnancy affected by: preeclampsia, eclampsia or fetal growth restriction. 2. Between 6 and 16 weeks gestation at time of enrollment.
Exclusion criteria
1. Current diagnosis and treatment of OSA. 2. Patient refusal to randomization. 3. Permanent Pacemaker (interfere with WATCHPAT sleep study). 4. Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study). 5. Coronary artery disease or congestive heart failure or cardiomyopathy. 6. Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD). 7. Inability to read or understand the consent. 8. \<18 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Pregnancy Outcomes | time of delivery | Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks) | early pregnancy (6-16 weeks) | Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only. Data were not collected for Control group at this time point. |
| Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) | 27-33 weeks | Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks). Data were not collected for Control group at this time point |
| Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group | 8-12 weeks postpartum | Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group. |
| Hospital Costs at Time of Delivery | Hospital costs at time of delivery | Hospital costs at time of delivery in treatment and control group. |
Countries
United States
Participant flow
Recruitment details
Enrollment. There were 714 women assessed for eligibility with N = 193 enrolled; n = 100 allocated to treatment group and n = 93 to the control group. In the treatment group there were n = 3 and n = 3 in the control group, respectively, loss to follow-up. The final analysis included n = 97 in the treatment group and n = 90 in the control group.
Participants by arm
| Arm | Count |
|---|---|
| Sleep Study + CPAP Group Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea | 100 |
| Standard Prenatal Care Group Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
Pre-natal care: Standard Pre-Natal Care | 93 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Sleep Study + CPAP Group | Standard Prenatal Care Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 93 Participants | 193 Participants |
| Age, Continuous | 29.1 years STANDARD_DEVIATION 4.8 | 28.8 years STANDARD_DEVIATION 5.2 | 29 years STANDARD_DEVIATION 5 |
| Pre-Pregnancy BMI | 34.5 kg/m^2 STANDARD_DEVIATION 7 | 33.3 kg/m^2 STANDARD_DEVIATION 6.8 | 33.9 kg/m^2 STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 16 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 20 Participants | 16 Participants | 36 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 10 Participants | 21 Participants |
| Race (NIH/OMB) White | 43 Participants | 46 Participants | 89 Participants |
| Region of Enrollment United States | 100 participants | 93 participants | 193 participants |
| Sex: Female, Male Female | 100 Participants | 93 Participants | 193 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 90 |
| other Total, other adverse events | 0 / 97 | 0 / 90 |
| serious Total, serious adverse events | 0 / 97 | 0 / 90 |
Outcome results
Primary
Number of Participants With Adverse Pregnancy Outcomes
Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
Time frame: time of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sleep Study + CPAP Group | Number of Participants With Adverse Pregnancy Outcomes | 45 Participants |
| Standard Prenatal Care Group | Number of Participants With Adverse Pregnancy Outcomes | 39 Participants |
Comparison: Fisher's Exact Testp-value: <0.05Fisher Exact
Secondary
Hospital Costs at Time of Delivery
Hospital costs at time of delivery in treatment and control group.
Time frame: Hospital costs at time of delivery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sleep Study + CPAP Group | Hospital Costs at Time of Delivery | 12185 dollars |
| Standard Prenatal Care Group | Hospital Costs at Time of Delivery | 12607 dollars |
p-value: <0.05t-test, 2 sided
Secondary
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only. Data were not collected for Control group at this time point.
Time frame: early pregnancy (6-16 weeks)
Population: Friedman's test was used to analyze differences in sleep study results at the three time points in experimental group. If significant differences are found in sleep study results a post hoc Wilcoxon Ranked Sign test will be used to compare differences at individual time points. Data were not collected for Control group at this time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sleep Study + CPAP Group | Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks) | No OSA | 89 Participants |
| Sleep Study + CPAP Group | Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks) | mild OSA | 3 Participants |
| Sleep Study + CPAP Group | Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks) | moderate OSA | 0 Participants |
| Sleep Study + CPAP Group | Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks) | severe OSA | 1 Participants |
p-value: <0.05Friedman test
Secondary
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.
Time frame: 8-12 weeks postpartum
Population: Incidence and Severity of OSA at 8-12 weeks postpartum. This is the only time point in which both groups completed sleep studies.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sleep Study + CPAP Group | Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group | Moderate OSA | 2 Participants |
| Sleep Study + CPAP Group | Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group | Severe OSA | 1 Participants |
| Sleep Study + CPAP Group | Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group | No OSA | 72 Participants |
| Sleep Study + CPAP Group | Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group | mild OSA | 14 Participants |
| Standard Prenatal Care Group | Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group | mild OSA | 9 Participants |
| Standard Prenatal Care Group | Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group | Moderate OSA | 2 Participants |
| Standard Prenatal Care Group | Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group | No OSA | 69 Participants |
| Standard Prenatal Care Group | Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group | Severe OSA | 0 Participants |
p-value: <0.05Friedman Test
Secondary
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks). Data were not collected for Control group at this time point
Time frame: 27-33 weeks
Population: Incidence and Severity of OSA in Late Pregnancy. Outcome data was only collected in the treatment group. Data were not collected for Control group at this time point
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sleep Study + CPAP Group | Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) | No OSA | 81 Participants |
| Sleep Study + CPAP Group | Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) | Mild OSA | 11 Participants |
| Sleep Study + CPAP Group | Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) | Moderate OSA | 0 Participants |
| Sleep Study + CPAP Group | Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) | Severe OSA | 0 Participants |
p-value: <0.05Friedman