Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
25 novembre 2019 mis à jour par: CAPT Dennis Spence, NC, USN, PhD, CRNA, United States Naval Medical Center, San Diego
Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
193
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
San Diego, California, États-Unis, 92134
- Naval Medical Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria
- 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.
- Between 6 and 16 weeks gestation at time of enrollment.
Exclusion Criteria
- Current diagnosis and treatment of OSA.
- Patient refusal to randomization.
- Permanent Pacemaker (interfere with WATCHPAT sleep study).
- Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
- Coronary artery disease or congestive heart failure or cardiomyopathy.
- Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD).
- Inability to read or understand the consent.
- <18 years of age.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Sleep Study + CPAP group
Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
|
Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
|
|
Autre: Standard Prenatal Care group
Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
|
Standard Pre-Natal Care
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Adverse Pregnancy Outcomes
Délai: 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)
|
time of delivery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
Délai: 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.
|
early pregnancy (6-16 weeks)
|
|
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
Délai: 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
|
27-33 weeks
|
|
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
Délai: 8-12 weeks postpartum
|
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
Délai: Hospital costs at time of delivery
|
Hospital costs at time of delivery in treatment and control group.
|
Hospital costs at time of delivery
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Directeur d'études: Dennis L Spence, PhD, United States Naval Medical Center, San Diego
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
- Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
- Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.
- Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 Sep;20(9):705-6. doi: 10.1093/sleep/20.9.705.
- Young T, Finn L, Peppard PE, Szklo-Coxe M, Austin D, Nieto FJ, Stubbs R, Hla KM. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008 Aug;31(8):1071-8.
- Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.
- 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. Erratum In: JAMA 2002 Oct 23-30;288(16):1985.
- American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):268-86. doi: 10.1097/ALN.0000000000000053. No abstract available.
- 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.
- Memtsoudis SG, Sun X, Chiu YL, Nurok M, Stundner O, Pastores SM, Mazumdar M. Utilization of critical care services among patients undergoing total hip and knee arthroplasty: epidemiology and risk factors. Anesthesiology. 2012 Jul;117(1):107-16. doi: 10.1097/ALN.0b013e31825afd36.
- Luque-Fernandez MA, Bain PA, Gelaye B, Redline S, Williams MA. Sleep-disordered breathing and gestational diabetes mellitus: a meta-analysis of 9,795 participants enrolled in epidemiological observational studies. Diabetes Care. 2013 Oct;36(10):3353-60. doi: 10.2337/dc13-0778.
- Ding XX, Wu YL, Xu SJ, Zhang SF, Jia XM, Zhu RP, Hao JH, Tao FB. A systematic review and quantitative assessment of sleep-disordered breathing during pregnancy and perinatal outcomes. Sleep Breath. 2014 Dec;18(4):703-13. doi: 10.1007/s11325-014-0946-4. Epub 2014 Feb 12.
- Pamidi S, Pinto LM, Marc I, Benedetti A, Schwartzman K, Kimoff RJ. Maternal sleep-disordered breathing and adverse pregnancy outcomes: a systematic review and metaanalysis. Am J Obstet Gynecol. 2014 Jan;210(1):52.e1-52.e14. doi: 10.1016/j.ajog.2013.07.033. Epub 2013 Aug 2.
- Louis J, Auckley D, Miladinovic B, Shepherd A, Mencin P, Kumar D, Mercer B, Redline S. Perinatal outcomes associated with obstructive sleep apnea in obese pregnant women. Obstet Gynecol. 2012 Nov;120(5):1085-92. doi: 10.1097/AOG.0b013e31826eb9d8.
- Ankichetty SP, Angle P, Joselyn AS, Chinnappa V, Halpern S. Anesthetic considerations of parturients with obesity and obstructive sleep apnea. J Anaesthesiol Clin Pharmacol. 2012 Oct;28(4):436-43. doi: 10.4103/0970-9185.101895.
- Reutrakul S, Zaidi N, Wroblewski K, Kay HH, Ismail M, Ehrmann DA, Van Cauter E. Interactions between pregnancy, obstructive sleep apnea, and gestational diabetes mellitus. J Clin Endocrinol Metab. 2013 Oct;98(10):4195-202. doi: 10.1210/jc.2013-2348. Epub 2013 Aug 21.
- Louis JM, Mogos MF, Salemi JL, Redline S, Salihu HM. Obstructive sleep apnea and severe maternal-infant morbidity/mortality in the United States, 1998-2009. Sleep. 2014 May 1;37(5):843-9. doi: 10.5665/sleep.3644.
- Facco FL, Ouyang DW, Zee PC, Grobman WA. Sleep disordered breathing in a high-risk cohort prevalence and severity across pregnancy. Am J Perinatol. 2014 Nov;31(10):899-904. doi: 10.1055/s-0033-1363768. Epub 2014 Feb 10.
- Pien GW, Pack AI, Jackson N, Maislin G, Macones GA, Schwab RJ. Risk factors for sleep-disordered breathing in pregnancy. Thorax. 2014 Apr;69(4):371-7. doi: 10.1136/thoraxjnl-2012-202718. Epub 2013 Nov 21.
- Morgenthaler TI, Aurora RN, Brown T, Zak R, Alessi C, Boehlecke B, Chesson AL Jr, Friedman L, Kapur V, Maganti R, Owens J, Pancer J, Swick TJ; Standards of Practice Committee of the AASM; American Academy of Sleep Medicine. Practice parameters for the use of autotitrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome: an update for 2007. An American Academy of Sleep Medicine report. Sleep. 2008 Jan;31(1):141-7. doi: 10.1093/sleep/31.1.141.
- Guilleminault C, Palombini L, Poyares D, Takaoka S, Huynh NT, El-Sayed Y. Pre-eclampsia and nasal CPAP: part 1. Early intervention with nasal CPAP in pregnant women with risk-factors for pre-eclampsia: preliminary findings. Sleep Med. 2007 Dec;9(1):9-14. doi: 10.1016/j.sleep.2007.04.020. Epub 2007 Jul 17.
- Whitehead C, Tong S, Wilson D, Howard M, Walker SP. Treatment of early-onset preeclampsia with continuous positive airway pressure. Obstet Gynecol. 2015 May;125(5):1106-1109. doi: 10.1097/AOG.0000000000000508.
- Facco F. Sleep-disordered breathing in pregnancy: a brief summary of current knowledge. BJOG. 2014 Dec;121(13):1694. doi: 10.1111/1471-0528.12888. Epub 2014 May 30. No abstract available.
- Izci-Balserak B, Pien GW. Sleep-disordered breathing and pregnancy: potential mechanisms and evidence for maternal and fetal morbidity. Curr Opin Pulm Med. 2010 Nov;16(6):574-82. doi: 10.1097/MCP.0b013e32833f0d55.
- Volna J, Kemlink D, Kalousova M, Vavrova J, Majerova V, Mestek O, Svarcova J, Sonka K, Zima T. Biochemical oxidative stress-related markers in patients with obstructive sleep apnea. Med Sci Monit. 2011 Sep;17(9):CR491-7. doi: 10.12659/msm.881935.
- Lyall F, Robson SC, Bulmer JN. Spiral artery remodeling and trophoblast invasion in preeclampsia and fetal growth restriction: relationship to clinical outcome. Hypertension. 2013 Dec;62(6):1046-54. doi: 10.1161/HYPERTENSIONAHA.113.01892. Epub 2013 Sep 23.
- Fung AM, Wilson DL, Lappas M, Howard M, Barnes M, O'Donoghue F, Tong S, Esdale H, Fleming G, Walker SP. Effects of maternal obstructive sleep apnoea on fetal growth: a prospective cohort study. PLoS One. 2013 Jul 24;8(7):e68057. doi: 10.1371/journal.pone.0068057. Print 2013.
- Reid J, Glew RA, Skomro R, Fenton M, Cotton D, Olatunbosun F, Gjevre J, Guilleminault C. Sleep disordered breathing and gestational hypertension: postpartum follow-up study. Sleep. 2013 May 1;36(5):717-721B. doi: 10.5665/sleep.2634.
- Hermes W, Tamsma JT, Grootendorst DC, Franx A, van der Post J, van Pampus MG, Bloemenkamp KW, Porath M, Mol BW, de Groot CJ. Cardiovascular risk estimation in women with a history of hypertensive pregnancy disorders at term: a longitudinal follow-up study. BMC Pregnancy Childbirth. 2013 Jun 4;13:126. doi: 10.1186/1471-2393-13-126.
- Chen YH, Kang JH, Lin CC, Wang IT, Keller JJ, Lin HC. Obstructive sleep apnea and the risk of adverse pregnancy outcomes. Am J Obstet Gynecol. 2012 Feb;206(2):136.e1-5. doi: 10.1016/j.ajog.2011.09.006. Epub 2011 Sep 16.
- Facco FL, Ouyang DW, Zee PC, Grobman WA. Development of a pregnancy-specific screening tool for sleep apnea. J Clin Sleep Med. 2012 Aug 15;8(4):389-94. doi: 10.5664/jcsm.2030.
- Hedner J, Pillar G, Pittman SD, Zou D, Grote L, White DP. A novel adaptive wrist actigraphy algorithm for sleep-wake assessment in sleep apnea patients. Sleep. 2004 Dec 15;27(8):1560-6. doi: 10.1093/sleep/27.8.1560.
- Penzel T, Kesper K, Pinnow I, Becker HF, Vogelmeier C. Peripheral arterial tonometry, oximetry and actigraphy for ambulatory recording of sleep apnea. Physiol Meas. 2004 Aug;25(4):1025-36. doi: 10.1088/0967-3334/25/4/019.
- Ahmadi N, Chung SA, Gibbs A, Shapiro CM. The Berlin questionnaire for sleep apnea in a sleep clinic population: relationship to polysomnographic measurement of respiratory disturbance. Sleep Breath. 2008 Mar;12(1):39-45. doi: 10.1007/s11325-007-0125-y.
- Rogers AE, Caruso CC, Aldrich MS. Reliability of sleep diaries for assessment of sleep/wake patterns. Nurs Res. 1993 Nov-Dec;42(6):368-72.
- Haythornthwaite JA, Hegel MT, Kerns RD. Development of a sleep diary for chronic pain patients. J Pain Symptom Manage. 1991 Feb;6(2):65-72. doi: 10.1016/0885-3924(91)90520-e.
- Finkel KJ, Searleman AC, Tymkew H, Tanaka CY, Saager L, Safer-Zadeh E, Bottros M, Selvidge JA, Jacobsohn E, Pulley D, Duntley S, Becker C, Avidan MS. Prevalence of undiagnosed obstructive sleep apnea among adult surgical patients in an academic medical center. Sleep Med. 2009 Aug;10(7):753-8. doi: 10.1016/j.sleep.2008.08.007. Epub 2009 Jan 30.
- Kalkhoff SM, Lutgendorf MA, Morrison TC, Han T, Spence DL. A randomized controlled trial of sleep study surveillance with targeted autoregulated positive airway pressure therapy for obstructive sleep apnea in pregnancy. Am J Obstet Gynecol MFM. 2022 May;4(3):100571. doi: 10.1016/j.ajogmf.2022.100571. Epub 2022 Jan 17.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 février 2017
Achèvement primaire (Réel)
14 octobre 2019
Achèvement de l'étude (Réel)
14 octobre 2019
Dates d'inscription aux études
Première soumission
11 mars 2016
Première soumission répondant aux critères de contrôle qualité
27 avril 2016
Première publication (Estimation)
29 avril 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 novembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 novembre 2019
Dernière vérification
1 novembre 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NMCSD.2016.0029
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Plan to submit manuscripts to appropriate journals and present data at appropriate conferences
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
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