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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02234765
Acronym
GESAP
Enrollment
280
Registered
2014-09-09
Start date
2014-05-31
Completion date
2016-05-31
Last updated
2017-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndrome

Keywords

OSA, OSAS, Sleep apnea, Management, Primary Care, Sleep Unit, Cost-Effectiveness, ESS

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.

Interventions

OTHERPrimary Care-based management

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

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

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Sociedad Española de Neumología y Cirugía Torácica
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in daytime sleepiness (ESS score) at 6 monthsbaseline and 6 monthsEpworth Sleepiness Scale (ESS)
Cost-effectiveness at 6 months6 monthsQUALYS

Secondary

MeasureTime frameDescription
CPAP compliance at 6 months6 monthsObjective data to be downloaded from the CPAP device
Adverse events at 6 months6 monthsAdverse events / secondary effects related to CPAP compliance.
Change from baseline in quality of lifebaseline and 6 monthsEuroQol (EQ5D)
Change from baseline in body mass indexBaseline and 6 months
Lost of follow up / Abandons at 6 months6 months
Change from baseline in blood pressureBaseline and 6 monthsOffice blood pressure
Satisfaction at 6 months6 monthsVisual analog scale

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026