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

Sociedad Española de Neumología y Cirugía Torácica

Status: Completed

Conditions: Sleep Apnea Syndrome

Treatments: Other: Standard management; Other: Primary Care-based management

Study type: Interventional

Funder types: Other

Identifiers

NCT02234765

PI13/02004

Details and patient eligibility

About

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."

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Sleep Unit

Active Comparator group

Description:

Patients diagnosed and followed up in the Sleep Unit.

Treatment:

Other: Standard management

Primary Care

Experimental group

Description:

Patients diagnosed and followed up in the Primary Care.

Treatment:

Other: Primary Care-based management