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Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness.
Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.
Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280 patients will be randomized for management on the basis of DNP (primary) or PSG (specialist), thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary. | Experimental | Diagnosis, autoCPAP, follow up. |
|
| Hospital | Active Comparator | Diagnosis, autoCPAP, follow up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnosis, autoCPAP, follow up. | Device | comparison between the efficacy of two protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale. | Before and after 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness of the exta- and intra-hospital management programs using DNP or PSG, evaluated by means of the Epworth scale and EuroQol 5D. | Before and after 6 months of follow-up |
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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 Fernando Masa Jiménez | Cáceres | Cáceres | 10005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29664672 | Derived | Sanchez-Quiroga MA, Corral J, Gomez-de-Terreros FJ, Carmona-Bernal C, Asensio-Cruz MI, Cabello M, Martinez-Martinez MA, Egea CJ, Ordax E, Barbe F, Barca J, Masa JF; Spanish Sleep Network and Primary Care Group. Primary Care Physicians Can Comprehensively Manage Patients with Sleep Apnea. A Noninferiority Randomized Controlled Trial. Am J Respir Crit Care Med. 2018 Sep 1;198(5):648-656. doi: 10.1164/rccm.201710-2061OC. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D003933 | Diagnosis |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |