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

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

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."

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndrome
• Intervention / Treatment: Other: Standard management; Other: Primary Care-based management

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25198
    • Hospital Arnau de Vilanova-Santa Maria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Sleep Unit; Patients diagnosed and followed up in the Sleep Unit.	Other: Standard management; Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
EXPERIMENTAL: Primary Care; Patients diagnosed and followed up in the Primary Care.	Other: Primary Care-based management; Patients will be diagnosed and follow-up in Primary Care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in daytime sleepiness (ESS score) at 6 months	Epworth Sleepiness Scale (ESS)	baseline and 6 months
Cost-effectiveness at 6 months	QUALYS	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in quality of life	EuroQol (EQ5D)	baseline and 6 months
Satisfaction at 6 months	Visual analog scale	6 months
CPAP compliance at 6 months	Objective data to be downloaded from the CPAP device	6 months
Adverse events at 6 months	Adverse events / secondary effects related to CPAP compliance.	6 months
Change from baseline in blood pressure	Office blood pressure	Baseline and 6 months
Change from baseline in body mass index		Baseline and 6 months
Lost of follow up / Abandons at 6 months		6 months

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica
• Collaborators: Instituto de Salud Carlos III

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (ESTIMATE): September 9, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Primary Care; OSA; Management; Sleep apnea; Cost-Effectiveness; ESS; OSAS; Sleep Unit
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Syndrome; Apnea
• Other Study ID Numbers: PI13/02004