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Completed

NCT Number: NCT02234765

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

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."

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Arnau de Vilanova-Santa María

Lleida, 25198, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary Care-based management

Other

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

Standard management

Other

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

Primary outcomes

  1. Change from baseline in daytime sleepiness (ESS score) at 6 months

    Time frame: baseline and 6 months

    Epworth Sleepiness Scale (ESS)

  2. Cost-effectiveness at 6 months

    Time frame: 6 months

    QUALYS

Secondary outcomes

  1. Change from baseline in quality of life

    Time frame: baseline and 6 months

    EuroQol (EQ5D)

  2. Satisfaction at 6 months

    Time frame: 6 months

    Visual analog scale

  3. CPAP compliance at 6 months

    Time frame: 6 months

    Objective data to be downloaded from the CPAP device

  4. Adverse events at 6 months

    Time frame: 6 months

    Adverse events / secondary effects related to CPAP compliance.

  5. Change from baseline in blood pressure

    Time frame: Baseline and 6 months

    Office blood pressure

  6. Change from baseline in body mass index

    Time frame: Baseline and 6 months

  7. Lost of follow up / Abandons at 6 months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: GESAP

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Sep 9, 2014
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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