- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02755831
Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
25. listopadu 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
193
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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California
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San Diego, California, Spojené státy, 92134
- Naval Medical Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Ženský
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Sleep Study + CPAP group
Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
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Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
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Jiný: Standard Prenatal Care group
Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
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Standard Pre-Natal Care
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of Participants With Adverse Pregnancy Outcomes
Časové okno: time of delivery
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Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
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time of delivery
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
Časové okno: early pregnancy (6-16 weeks)
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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.
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early pregnancy (6-16 weeks)
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Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
Časové okno: 27-33 weeks
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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
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27-33 weeks
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Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
Časové okno: 8-12 weeks postpartum
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Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.
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8-12 weeks postpartum
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Hospital Costs at Time of Delivery
Časové okno: Hospital costs at time of delivery
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Hospital costs at time of delivery in treatment and control group.
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Hospital costs at time of delivery
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Ředitel studie: Dennis L Spence, PhD, United States Naval Medical Center, San Diego
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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- 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.
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- 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.
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- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
20. února 2017
Primární dokončení (Aktuální)
14. října 2019
Dokončení studie (Aktuální)
14. října 2019
Termíny zápisu do studia
První předloženo
11. března 2016
První předloženo, které splnilo kritéria kontroly kvality
27. dubna 2016
První zveřejněno (Odhad)
29. dubna 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
27. listopadu 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. listopadu 2019
Naposledy ověřeno
1. listopadu 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NMCSD.2016.0029
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Plan to submit manuscripts to appropriate journals and present data at appropriate conferences
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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