Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitus in Pregnancy: Protocol for Feasibility Randomized Controlled Trial
BackgroundObstructive sleep apnea (OSA) is a common sleep disorder, and in pregnancy, it is associated with an increased risk of complications, including gestational diabetes mellitus and preeclampsia. Supine sleep may worsen OSA, and in pregnancy, it is associated with an in...
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JMIR Publications
2025-04-01
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| Series: | JMIR Research Protocols |
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| author | Frances Clements Hima Vedam Yewon Chung John Smoleniec Colin Sullivan Renuka Shanmugalingam Annemarie Hennessy Angela Makris |
| author_facet | Frances Clements Hima Vedam Yewon Chung John Smoleniec Colin Sullivan Renuka Shanmugalingam Annemarie Hennessy Angela Makris |
| author_sort | Frances Clements |
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BackgroundObstructive sleep apnea (OSA) is a common sleep disorder, and in pregnancy, it is associated with an increased risk of complications, including gestational diabetes mellitus and preeclampsia. Supine sleep may worsen OSA, and in pregnancy, it is associated with an increased risk of stillbirth due to effects on fetomaternal blood flow. Continuous positive airway pressure (CPAP) therapy is considered the gold-standard treatment for moderate to severe OSA, although compliance is frequently poor; positional therapy (PT) is generally less effective than CPAP in nonpregnant patients but may be better tolerated and more accessible during pregnancy. There is limited data on whether widespread, early screening for sleep disorders in pregnant women with symptoms of sleep-disordered breathing or at high risk of metabolic complications and subsequent early intervention with CPAP or PT attenuates fetomaternal risks.
ObjectiveThis study aims to determine the feasibility of conducting a randomized controlled trial to assess improved fetomaternal outcomes in a high-risk pregnant population with OSA, using CPAP or PT, initiated by the 16th week of gestation.
MethodsThis study is a randomized, controlled, open-label feasibility study in which pregnant women with an apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) ≥5 are treated with CPAP (auto-titrating and fixed pressure) or positional therapy from early gestation (by 16 weeks) until delivery. The primary outcome is the feasibility of the study protocol and the development of gestational diabetes mellitus by the 28-week gestation period. Secondary outcomes include the development of hypertensive disorders of pregnancy (HDP), maternal weight gain, uterine artery blood flow, glycemic control during pregnancy (in participants who develop gestational diabetes), changes in maternal circulating biomarkers, and neonatal birthweight complications. Polysomnography at 28- to 32-week gestation period, postpartum polysomnography, therapy compliance, and patient acceptability are also assessed.
ResultsThe trial commenced on September 30, 2019. The trial is ongoing as of August 6, 2024.
ConclusionsThe trial intends to contribute to the growing evidence base to support the need for the identification and treatment of OSA occurring during pregnancy and to assess the feasibility of the study protocol. This will be the first trial to compare the early initiation of CPAP (auto-titrating and fixed pressure) and positional therapy in pregnant women from early gestation, providing alternative therapies for the treatment of OSA in this important population.
Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12619001530112; https://tinyurl.com/yctdzs4u
International Registered Report Identifier (IRRID)DERR1-10.2196/51434 |
| format | Article |
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| institution | DOAJ |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | JMIR Publications |
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| spelling | doaj-art-efa586a8c8d44e2bba31f08a55d662822025-08-20T03:08:59ZengJMIR PublicationsJMIR Research Protocols1929-07482025-04-0114e5143410.2196/51434Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitus in Pregnancy: Protocol for Feasibility Randomized Controlled TrialFrances Clementshttps://orcid.org/0000-0002-3146-6028Hima Vedamhttps://orcid.org/0000-0002-0515-8670Yewon Chunghttps://orcid.org/0000-0003-0692-6608John Smoleniechttps://orcid.org/0000-0003-4909-3634Colin Sullivanhttps://orcid.org/0000-0002-2324-8055Renuka Shanmugalingamhttps://orcid.org/0000-0002-2255-8369Annemarie Hennessyhttps://orcid.org/0000-0002-5975-2843Angela Makrishttps://orcid.org/0000-0002-1636-3493 BackgroundObstructive sleep apnea (OSA) is a common sleep disorder, and in pregnancy, it is associated with an increased risk of complications, including gestational diabetes mellitus and preeclampsia. Supine sleep may worsen OSA, and in pregnancy, it is associated with an increased risk of stillbirth due to effects on fetomaternal blood flow. Continuous positive airway pressure (CPAP) therapy is considered the gold-standard treatment for moderate to severe OSA, although compliance is frequently poor; positional therapy (PT) is generally less effective than CPAP in nonpregnant patients but may be better tolerated and more accessible during pregnancy. There is limited data on whether widespread, early screening for sleep disorders in pregnant women with symptoms of sleep-disordered breathing or at high risk of metabolic complications and subsequent early intervention with CPAP or PT attenuates fetomaternal risks. ObjectiveThis study aims to determine the feasibility of conducting a randomized controlled trial to assess improved fetomaternal outcomes in a high-risk pregnant population with OSA, using CPAP or PT, initiated by the 16th week of gestation. MethodsThis study is a randomized, controlled, open-label feasibility study in which pregnant women with an apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) ≥5 are treated with CPAP (auto-titrating and fixed pressure) or positional therapy from early gestation (by 16 weeks) until delivery. The primary outcome is the feasibility of the study protocol and the development of gestational diabetes mellitus by the 28-week gestation period. Secondary outcomes include the development of hypertensive disorders of pregnancy (HDP), maternal weight gain, uterine artery blood flow, glycemic control during pregnancy (in participants who develop gestational diabetes), changes in maternal circulating biomarkers, and neonatal birthweight complications. Polysomnography at 28- to 32-week gestation period, postpartum polysomnography, therapy compliance, and patient acceptability are also assessed. ResultsThe trial commenced on September 30, 2019. The trial is ongoing as of August 6, 2024. ConclusionsThe trial intends to contribute to the growing evidence base to support the need for the identification and treatment of OSA occurring during pregnancy and to assess the feasibility of the study protocol. This will be the first trial to compare the early initiation of CPAP (auto-titrating and fixed pressure) and positional therapy in pregnant women from early gestation, providing alternative therapies for the treatment of OSA in this important population. Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12619001530112; https://tinyurl.com/yctdzs4u International Registered Report Identifier (IRRID)DERR1-10.2196/51434https://www.researchprotocols.org/2025/1/e51434 |
| spellingShingle | Frances Clements Hima Vedam Yewon Chung John Smoleniec Colin Sullivan Renuka Shanmugalingam Annemarie Hennessy Angela Makris Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitus in Pregnancy: Protocol for Feasibility Randomized Controlled Trial JMIR Research Protocols |
| title | Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitus in Pregnancy: Protocol for Feasibility Randomized Controlled Trial |
| title_full | Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitus in Pregnancy: Protocol for Feasibility Randomized Controlled Trial |
| title_fullStr | Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitus in Pregnancy: Protocol for Feasibility Randomized Controlled Trial |
| title_full_unstemmed | Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitus in Pregnancy: Protocol for Feasibility Randomized Controlled Trial |
| title_short | Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitus in Pregnancy: Protocol for Feasibility Randomized Controlled Trial |
| title_sort | effect of continuous positive airway pressure or positional therapy compared to control for treatment of obstructive sleep apnea on the development of gestational diabetes mellitus in pregnancy protocol for feasibility randomized controlled trial |
| url | https://www.researchprotocols.org/2025/1/e51434 |
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