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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02234765
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : February 14, 2017
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica

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."

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndrome Other: Primary Care-based management Other: Standard management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Management of Patients With Suspected Sleep Apnea Syndrome From Primary Care: Territorial Assistance Network.
Actual Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234765


Locations
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Spain
Hospital Arnau de Vilanova-Santa María
Lleida, Spain, 25198
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Ferran Barbe, MD Hospital Arnau de Vilanova. IRB Lleida. CIBERes

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ferran Barbe, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT02234765     History of Changes
Other Study ID Numbers: PI13/02004
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica:
OSA
OSAS
Sleep apnea
Management
Primary Care
Sleep Unit
Cost-Effectiveness
ESS

Additional relevant MeSH terms:
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Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases