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

NCT ID: NCT02234765

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-05-31

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."

Conditions

Sleep Apnea Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Sleep Unit

Patients diagnosed and followed up in the Sleep Unit.

Group Type: ACTIVE_COMPARATOR

Standard management

Intervention Type: OTHER

Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.

Primary Care

Patients diagnosed and followed up in the Primary Care.

Group Type: EXPERIMENTAL

Primary Care-based management

Intervention Type: OTHER

Patients will be diagnosed and follow-up in Primary Care.

Interventions

Primary Care-based management

Patients will be diagnosed and follow-up in Primary Care.

Intervention Type: OTHER

Standard management

Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: lead

Responsible Party

Ferran Barbe

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferran Barbe, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Arnau de Vilanova. IRB Lleida. CIBERes

Locations

Hospital Arnau de Vilanova-Santa María

Lleida, Lleida, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 30064993 (View on PubMed)

Other Identifiers

PI13/02004

Identifier Type: -

Identifier Source: org_study_id