دورية أكاديمية
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Conventional Polysomnography Is Not Necessary for the Management of Most Patients with Suspected Obstructive Sleep Apnea. Noninferiority, Randomized Controlled Trial.

التفاصيل البيبلوغرافية
العنوان: Conventional Polysomnography Is Not Necessary for the Management of Most Patients with Suspected Obstructive Sleep Apnea. Noninferiority, Randomized Controlled Trial.
المؤلفون: Corral J; 1 San Pedro de Alcántara Hospital, Cáceres, Spain.; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain., Sánchez-Quiroga MÁ; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 3 Virgen del Puerto Hospital, Plasencia, Cáceres, Spain., Carmona-Bernal C; 4 Virgen del Rocío Hospital, Sevilla, Spain., Sánchez-Armengol Á; 4 Virgen del Rocío Hospital, Sevilla, Spain., de la Torre AS; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 5 Arnau de Vilanova y Santa María Hospital, Lleida, Spain., Durán-Cantolla J; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 6 Organización Sanitaria Integrada Araba University Hospital, Bioaraba Research Institute, Vitoria, Spain., Egea CJ; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 6 Organización Sanitaria Integrada Araba University Hospital, Bioaraba Research Institute, Vitoria, Spain., Salord N; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 7 Bellvitge Hospital, Hospitalet de Llobregat, Barcelona, Spain., Monasterio C; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 7 Bellvitge Hospital, Hospitalet de Llobregat, Barcelona, Spain., Terán J; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 8 Burgos University Hospital, Burgos, Spain., Alonso-Alvarez ML; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 8 Burgos University Hospital, Burgos, Spain., Muñoz-Méndez J; 9 12 de Octubre Hospital, Madrid, Spain., Arias EM; 9 12 de Octubre Hospital, Madrid, Spain., Cabello M; 10 Marqués de Valdecilla Hospital, Santander, Spain., Montserrat JM; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 11 Clinic Hospital, Barcelona, Spain., De la Peña M; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 12 Son Espases Hospital, Mallorca, Spain; and., Serrano JC; 13 Llerena-Zafra Hospital, Zafra, Badajoz, Spain., Barbe F; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.; 5 Arnau de Vilanova y Santa María Hospital, Lleida, Spain., Masa JF; 1 San Pedro de Alcántara Hospital, Cáceres, Spain.; 2 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.
مؤلفون مشاركون: Spanish Sleep Network
المصدر: American journal of respiratory and critical care medicine [Am J Respir Crit Care Med] 2017 Nov 01; Vol. 196 (9), pp. 1181-1190.
نوع المنشور: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: American Thoracic Society Country of Publication: United States NLM ID: 9421642 Publication Model: Print Cited Medium: Internet ISSN: 1535-4970 (Electronic) Linking ISSN: 1073449X NLM ISO Abbreviation: Am J Respir Crit Care Med Subsets: MEDLINE
أسماء مطبوعة: Publication: 2000- : New York, NY : American Thoracic Society
Original Publication: New York, NY : American Lung Association, c1994-
مواضيع طبية MeSH: Home Care Services*, Continuous Positive Airway Pressure/*methods , Polysomnography/*methods , Sleep Apnea, Obstructive/*diagnosis , Sleep Apnea, Obstructive/*therapy, Cost-Benefit Analysis ; Female ; Humans ; Male ; Middle Aged ; Reproducibility of Results ; Spain
مستخلص: Rationale: Home respiratory polygraphy may be a simpler alternative to in-laboratory polysomnography for the management of more symptomatic patients with obstructive sleep apnea, but its effectiveness has not been evaluated across a broad clinical spectrum.
Objectives: To compare the long-term effectiveness (6 mo) of home respiratory polygraphy and polysomnography management protocols in patients with intermediate-to-high sleep apnea suspicion (most patients requiring a sleep study).
Methods: A multicentric, noninferiority, randomized controlled trial with two open parallel arms and a cost-effectiveness analysis was performed in 12 tertiary hospitals in Spain. Sequentially screened patients with sleep apnea suspicion were randomized to respiratory polygraphy or polysomnography protocols. Moreover, both arms received standardized therapeutic decision-making, continuous positive airway pressure (CPAP) treatment or a healthy habit assessment, auto-CPAP titration (for CPAP indication), health-related quality-of-life questionnaires, 24-hour blood pressure monitoring, and polysomnography at the end of follow-up. The main outcome was the Epworth Sleepiness Scale measurement. The noninferiority criterion was -2 points on the Epworth scale.
Measurements and Main Results: In total, 430 patients were randomized. The respiratory polygraphy protocol was noninferior to the polysomnography protocol based on the Epworth scale. Quality of life, blood pressure, and polysomnography were similar between protocols. Respiratory polygraphy was the most cost-effective protocol, with a lower per-patient cost of 416.7€.
Conclusions: Home respiratory polygraphy management is similarly effective to polysomnography, with a substantially lower cost. Therefore, polysomnography is not necessary for most patients with suspected sleep apnea. This finding could change established clinical practice, with a clear economic benefit. Clinical trial registered with www.clinicaltrials.gov (NCT 01752556).
التعليقات: Comment in: Am J Respir Crit Care Med. 2017 Nov 1;196 (9):1096-1098. (PMID: 28661700)
Comment in: Ann Intern Med. 2018 Feb 20;168(4):JC20. (PMID: 29459957)
فهرسة مساهمة: Investigator: R Pereira; E Garcia-Ledesma; FJ Gómez de Terreros; M Merchan; P Mañas; MI Asensio-Cruz; S Gómez; A Cortijo; A Álvarez-Ruiz de Larrinaga; J Marcos Cabrero; M Gasa; S Pérez-Ramos; E Ordax; T Díaz-Cambriles; MÁ Martínez-Martínez; O Cantalejo; M Torres; N Toledo-Pons; Á Ortega-González; FJ Barca
Keywords: cost-effectiveness; home respiratory polygraphy; portable monitor; sleep apnea
سلسلة جزيئية: ClinicalTrials.gov NCT01752556
تواريخ الأحداث: Date Created: 20170622 Date Completed: 20171120 Latest Revision: 20220310
رمز التحديث: 20240628
DOI: 10.1164/rccm.201612-2497OC
PMID: 28636405
قاعدة البيانات: MEDLINE
الوصف
تدمد:1535-4970
DOI:10.1164/rccm.201612-2497OC