Clinical trial NCT02234765: Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care
Official title: Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome
Keywords: OSA
OSAS
Sleep apnea
Management
Primary Care
Sleep Unit
Cost-Effectiveness
ESS
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2014-09-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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."


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in daytime sleepiness (ESS score) at 6 months
timeFrame: baseline and 6 months
measure: Cost-effectiveness at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in quality of life
timeFrame: baseline and 6 months
measure: Satisfaction at 6 months
timeFrame: 6 months
measure: CPAP compliance at 6 months
timeFrame: 6 months
measure: Adverse events at 6 months
timeFrame: 6 months
measure: Change from baseline in blood pressure
timeFrame: Baseline and 6 months
measure: Change from baseline in body mass index
timeFrame: Baseline and 6 months
measure: Lost of follow up / Abandons at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova-Santa María
Study officials:
affiliation: Hospital Arnau de Vilanova. IRB Lleida. CIBERes
name: Ferran Barbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.