Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care

Study Overview
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Brief Summary
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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.

Official Title
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Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.

Conditions
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Sleep Apnea Syndrome

Intervention / Treatment
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* Other: Primary Care-based management
* Other: Standard management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women over 18 years old Suspected OSA patients (chronic snoring, apneas, excessive daytime sleepiness) or resistant hypertension Written informed consent signed Exclusion Criteria: Patients with impaired lung function (sd. overlap, obesity hypoventilation, and restrictive disorders) Severe heart failure Severe chronic pathology associated Psychiatric disorder Periodic leg movements Pregnancy Other dyssomnias or parasomnias Patients already treated with CPAP

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleep Unit<br>Patients diagnosed and followed up in the Sleep Unit. | Other: Standard management<br>* Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.<br>|
| Experimental: Primary Care<br>Patients diagnosed and followed up in the Primary Care. | Other: Primary Care-based management<br>* Patients will be diagnosed and follow-up in Primary Care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, OSAS, Sleep apnea, Management, Primary Care, Sleep Unit, Cost-Effectiveness, ESS