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Primary objectives:
The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against polysomnography (PSG) using the Epworth scale;
Secondary Objective:
Design: Prospective, randomized, controlled, open, parallel noninferiority. 440 patients will be randomized to diagnose and follow treatment based on the PR or PSG generating four groups: two treated and two untreated with CPAP. The latter did not undergo self-certification home. The monitoring will be 6 months and 4 assessments. Statistical analysis: compare the change of the scale Epworth before and after the intervention between both treatment arms using analysis of covariance. The premise is non-inferiority of -1.6 at the lower limit of 95%. Secondary variables were analyzed by independent means differences (or nonparametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: the costs generated by the two methods will be measured against the effectiveness of the primary endpoint using Bayesian techniques
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospital diagnosis | Active Comparator | diagnosis of Sleep Apnea and therapeutic decision will perform according to polysomnography |
|
| Home diagnosis | Experimental | diagnosis of Sleep Apnea and therapeutic decision will be perform according to home respiratory polygraphy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diagnosis and therapeutic decision | Procedure | A conventional polysomnography will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 moths |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the efficacy of diagnosis and therapeutic decision-making evaluated using Epworth sleepiness scale as primary variable in patients managed by home RP and by PSG after six months of follow-up. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D. | Six months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan F. Masa, MD | Hospital San Pedro de Alcántara. Cáceres. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juan F. Masa | Cáceres | Cáceres | 10005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28636405 | Derived | Corral J, Sanchez-Quiroga MA, Carmona-Bernal C, Sanchez-Armengol A, de la Torre AS, Duran-Cantolla J, Egea CJ, Salord N, Monasterio C, Teran J, Alonso-Alvarez ML, Munoz-Mendez J, Arias EM, Cabello M, Montserrat JM, De la Pena M, Serrano JC, Barbe F, Masa JF; Spanish Sleep Network. Conventional Polysomnography Is Not Necessary for the Management of Most Patients with Suspected Obstructive Sleep Apnea. Noninferiority, Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1181-1190. doi: 10.1164/rccm.201612-2497OC. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| diagnosis and therapeutic decision | Procedure | A home respiratory polygraphy will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 months |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |