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

Sleep Apnea Syndrome Clinical Trial

— GESAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234765
• Other study ID #: PI13/02004
• Status: Completed
• Phase: N/A
• First received: September 2, 2014
• Last updated: February 13, 2017
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: February 2017
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Other:
• Primary Care-based management
Patients will be diagnosed and follow-up in Primary Care.
• Standard management
Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.

Locations

Country	Name	City	State
Spain	Hospital Arnau de Vilanova-Santa María	Lleida

Sponsors (2)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in daytime sleepiness (ESS score) at 6 months	Epworth Sleepiness Scale (ESS)	baseline and 6 months
Primary	Cost-effectiveness at 6 months	QUALYS	6 months
Secondary	Change from baseline in quality of life	EuroQol (EQ5D)	baseline and 6 months
Secondary	Satisfaction at 6 months	Visual analog scale	6 months
Secondary	CPAP compliance at 6 months	Objective data to be downloaded from the CPAP device	6 months
Secondary	Adverse events at 6 months	Adverse events / secondary effects related to CPAP compliance.	6 months
Secondary	Change from baseline in blood pressure	Office blood pressure	Baseline and 6 months
Secondary	Change from baseline in body mass index		Baseline and 6 months
Secondary	Lost of follow up / Abandons at 6 months		6 months