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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Fundacio Catalana de Pneumologia | OTHER |
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The objective of the study is to compare the results of a coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation.
Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment with (CPAP). Participating center is Hospital Santa MarÃa-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Unit group | No Intervention | This group will have standard follow up in sleep unit at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling. | |
| Primary Care group | Experimental | This group will have standard follow up in primary care at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical follow up by general practitioners in primary care | Other | The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of hours of use per day of CPAP | Number of hours of use per day of CPAP according to the internal clock of the CPAP device | Six month |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime sleepiness | Epworth Sleepiness Scale (ESS) | At baseline and at 6 month of follow-up |
| Patient satisfaction | visual analog scale (0-10) |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index | Six month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ferran Barbe, MD | Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain) | Study Director |
| Cristina Esquinas, RN, MPH | Hospital Arnau Vilanova-Santa Maria, Lleida (Spain) | Principal Investigator |
| Nuria Nadal, MD | Primary Care. National Health Institute. Lleida (Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital santa Maria | Lleida | Catalonia | 25198 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25766689 | Derived | Sanchez-de-la-Torre M, Nadal N, Cortijo A, Masa JF, Duran-Cantolla J, Valls J, Serra S, Sanchez-de-la-Torre A, Gracia M, Ferrer F, Lorente I, Urgeles MC, Alonso T, Fuentes A, Armengol F, Lumbierres M, Vazquez-Polo FJ, Barbe F; Respiratory Medicine Research Group. Role of primary care in the follow-up of patients with obstructive sleep apnoea undergoing CPAP treatment: a randomised controlled trial. Thorax. 2015 Apr;70(4):346-52. doi: 10.1136/thoraxjnl-2014-206287. |
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| ID | Term |
|---|---|
| D011320 | Primary Health Care |
| ID | Term |
|---|---|
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Six month |
| Adverse events | Adverse events related to CPAP treatment | Six month |
| Quality of life | EuroQol | Baseline and at 6 month of follow up |
| Cost-efficacy evaluation | Qualys | Six month |
| Comorbidity index | Charlson index | Six month |
| Blood pressure | Office blood pressure | Sixt month |
| Lost of follow up | Percentage of patients lost during follow up | Six month |