This trial is active, not recruiting.

Condition sleep apnea syndrome
Treatments primary care-based management, standard management
Sponsor Sociedad Española de Neumología y Cirugía Torácica
Collaborator Instituto de Salud Carlos III
Start date May 2014
End date December 2016
Trial size 280 participants
Trial identifier NCT02234765, PI13/02004


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."

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
(Active Comparator)
Patients diagnosed and followed up in the Sleep Unit.
standard management
Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
Patients diagnosed and followed up in the Primary Care.
primary care-based management
Patients will be diagnosed and follow-up in Primary Care.

Primary Outcomes

Change from baseline in daytime sleepiness (ESS score) at 6 months
time frame: baseline and 6 months
Cost-effectiveness at 6 months
time frame: 6 months

Secondary Outcomes

Change from baseline in quality of life
time frame: baseline and 6 months
Satisfaction at 6 months
time frame: 6 months
CPAP compliance at 6 months
time frame: 6 months
Adverse events at 6 months
time frame: 6 months
Change from baseline in blood pressure
time frame: Baseline and 6 months
Change from baseline in body mass index
time frame: Baseline and 6 months
Lost of follow up / Abandons at 6 months
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.
Principal investigator Ferran Barbe, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Sociedad Española de Neumología y Cirugía Torácica.