Conventional Polysomnography Is Not Necessary for the Management of Most Patients with Suspected Obstructive Sleep Apnea. Noninferiority, Randomized Controlled Trial
| Autor: | Jaime Corral, Maria-Ángeles Sánchez-Quiroga, Carmen Carmona-Bernal, Ángeles Sánchez-Armengol, Alicia Sánchez de la Torre, Joaquín Durán-Cantolla, Carlos J. Egea, Neus Salord, Carmen Monasterio, Joaquín Terán, M. Luz Alonso-Alvarez, Jesús Muñoz-Méndez, Eva M. Arias, Marta Cabello, Josep M. Montserrat, Mónica De la Peña, José C. Serrano, Ferran Barbe, Juan F. Masa, Ricardo Pereira, Estefanía Garcia-Ledesma, Francisco J. Gómez de Terreros, Miguel Merchan, Pedro Mañas, M. Isabel Asensio-Cruz, Silvia Gómez, Anunciación Cortijo, Ainhoa Álvarez-Ruiz de Larrinaga, Jaime Marcos Cabrero, Mercé Gasa, Sandra Pérez-Ramos, Estrella Ordax, Trinidad Díaz-Cambriles, M. Ángeles Martínez-Martínez, Olga Cantalejo, Marta Torres, Nuria Toledo-Pons, Ángel Ortega-González, F. Javier Barca |
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| Rok vydání: | 2017 |
| Předmět: |
Pulmonary and Respiratory Medicine
Male medicine.medical_specialty Cost effectiveness medicine.medical_treatment Cost-Benefit Analysis Polysomnography Critical Care and Intensive Care Medicine Respiratory polygraphy law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law medicine Humans Continuous positive airway pressure Intensive care medicine Sleep Apnea Obstructive medicine.diagnostic_test Continuous Positive Airway Pressure business.industry Sleep apnea Reproducibility of Results Middle Aged medicine.disease Home Care Services Obstructive sleep apnea 030228 respiratory system Spain Female business 030217 neurology & neurosurgery |
| Zdroj: | American journal of respiratory and critical care medicine. 196(9) |
| ISSN: | 1535-4970 |
| Popis: | 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.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).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.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€.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). |
| Databáze: | OpenAIRE |
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