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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
Obstructive sleep apnea syndrome (OSA) is characterized by the manifestation of excessive sleepiness secondary to repeated obstruction of the upper airway during sleep and cognitive-behavioral, respiratory, cardiac, metabolic or inflammatory disorders. Epidemiological studies in our country have shown that OSA is a highly prevalent disease in the general population, affecting 2-4% of the adult population. The most important clinical manifestations of OSAS is a deterioration in the quality of life and an increase in cardiovascular disease. OSA is also associated with traffic accidents. Therefore, and considering the medical complications of OSA, as well as the sociolaboral impact and its negative impact on quality of life and survival; is stated that this disease is a public health problem that requires the physician to identify patients eligible to treatment. Moreover, it has been shown that undiagnosed patients, duplicate the consumption of health resources, comparing when the diagnosis and treatment has been established. Finally, we have a highly effective treatment using positive pressure in the upper airway (CPAP) that has been shown to be effective and cost-effective. The current situation in which all patients diagnosed with OSA and receiving different treatments are monitored and controlled by the Sleep Units (SU) is an oversized medicine specialist at the expense of primary care (PC). Our working hypothesis is: "By the coordination of actions at various levels including interactive training equipment AP, use the bilateral (SU-AP) of electronic medical records and the use of new technologies can be achieved in AP satisfactory management of the diagnostic and therapeutic process of patients with suspected OSA. Patients assisted in both areas have a level of clinical response, satisfaction, compliance and avoidance of complications, similar to that obtained with monitoring by SU. In addition, management by AP will be more cost-effective than in the SU."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Unit | Active Comparator | Patients diagnosed and followed up in the Sleep Unit. |
|
| Primary Care | Experimental | Patients diagnosed and followed up in the Primary Care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Care-based management | Other | Patients will be diagnosed and follow-up in Primary Care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in daytime sleepiness (ESS score) at 6 months | Epworth Sleepiness Scale (ESS) | baseline and 6 months |
| Cost-effectiveness at 6 months | QUALYS | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in quality of life | EuroQol (EQ5D) | baseline and 6 months |
| Satisfaction at 6 months | Visual analog scale | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ferran Barbe, MD | Hospital Arnau de Vilanova. IRB Lleida. CIBERes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Arnau de Vilanova-Santa MarÃa | Lleida | Lleida | 25198 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30064993 | Derived | Tarraubella N, Sanchez-de-la-Torre M, Nadal N, De Batlle J, Benitez I, Cortijo A, Urgeles MC, Sanchez V, Lorente I, Lavega MM, Fuentes A, Clotet J, Llort L, Vilo L, Juni MC, Juarez A, Gracia M, Castro-Grattoni AL, Pascual L, Minguez O, Masa JF, Barbe F. Management of obstructive sleep apnoea in a primary care vs sleep unit setting: a randomised controlled trial. Thorax. 2018 Dec;73(12):1152-1160. doi: 10.1136/thoraxjnl-2017-211237. Epub 2018 Jul 31. |
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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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| Standard management | Other | Standard management according to Spanish Respiratory Society guidelines in Sleep Unit. |
|
| CPAP compliance at 6 months | Objective data to be downloaded from the CPAP device | 6 months |
| Adverse events at 6 months | Adverse events / secondary effects related to CPAP compliance. | 6 months |
| Change from baseline in blood pressure | Office blood pressure | Baseline and 6 months |
| Change from baseline in body mass index | Baseline and 6 months |
| Lost of follow up / Abandons at 6 months | 6 months |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |