Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
25. november 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
193
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
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San Diego, California, Forenede Stater, 92134
- Naval Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Andet: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Adverse Pregnancy Outcomes
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
Tidsramme: 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.
|
early pregnancy (6-16 weeks)
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Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
Tidsramme: 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
|
27-33 weeks
|
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Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
Tidsramme: 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
|
|
Hospital Costs at Time of Delivery
Tidsramme: Hospital costs at time of delivery
|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Dennis L Spence, PhD, United States Naval Medical Center, San Diego
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- 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.
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- 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.
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- 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.
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- 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.
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- 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.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. februar 2017
Primær færdiggørelse (Faktiske)
14. oktober 2019
Studieafslutning (Faktiske)
14. oktober 2019
Datoer for studieregistrering
Først indsendt
11. marts 2016
Først indsendt, der opfyldte QC-kriterier
27. april 2016
Først opslået (Skøn)
29. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NMCSD.2016.0029
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Plan to submit manuscripts to appropriate journals and present data at appropriate conferences
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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