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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Study + CPAP group | Experimental | Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment |
|
| Standard Prenatal Care group | Other | Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | early pregnancy (6-16 weeks) |
| Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dennis L Spence, PhD | United States Naval Medical Center, San Diego | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center | San Diego | California | 92134 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17644475 | Background | Poyares D, Guilleminault C, Hachul H, Fujita L, Takaoka S, Tufik S, Sass N. Pre-eclampsia and nasal CPAP: part 2. Hypertension during pregnancy, chronic snoring, and early nasal CPAP intervention. Sleep Med. 2007 Dec;9(1):15-21. doi: 10.1016/j.sleep.2007.04.019. Epub 2007 Jul 20. | |
| 10770144 | Background | Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829. |
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Plan to submit manuscripts to appropriate journals and present data at appropriate conferences
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Standard Prenatal Care Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Count of Participants | Participants | time of delivery |
|
Adverse data collected after time of enrollment to study completion ( February 20, 2017 - October 14, 2019). Subjects were enrolled starting at 6 to 12 weeks gestation and were followed until approximately 3 months postpartum (8 to 12 weeks postpartum).
No adverse events occurred
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CAPTAIN Dennis Spence, NC, USN, PhD, CRNA | Naval Medical Center San Diego | 6199161680 | dennis.l.spence.mil@mail.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2016 | Nov 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D011225 | Pre-Eclampsia |
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Pre-natal care | Other | Standard Pre-Natal Care |
|
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 |
| 27-33 weeks |
| 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. | 8-12 weeks postpartum |
| Hospital Costs at Time of Delivery | Hospital costs at time of delivery in treatment and control group. | Hospital costs at time of delivery |
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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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-Pregnancy BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | early pregnancy (6-16 weeks) |
|
|
|
|
| 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 | 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 | Posted | Count of Participants | Participants | 27-33 weeks |
|
|
|
|
| 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. | Incidence and Severity of OSA at 8-12 weeks postpartum. This is the only time point in which both groups completed sleep studies. | Posted | Count of Participants | Participants | 8-12 weeks postpartum |
|
|
|
|
| Secondary | Hospital Costs at Time of Delivery | Hospital costs at time of delivery in treatment and control group. | Posted | Mean | 95% Confidence Interval | dollars | Hospital costs at time of delivery |
|
|
|
|
| 0 |
| 97 |
| 0 |
| 97 |
| 0 |
| 97 |
| EG001 | 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 | 0 | 90 | 0 | 90 | 0 | 90 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| severe OSA |
|
| Severe OSA |
|
| Moderate OSA |
|
| Severe OSA |
|