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Pathophysiology of the Upper Airway in Patients With COPD and Concomitant OSA

5 de mayo de 2020 actualizado por: Robert L. Owens, University of California, San Diego

Pathophysiology of the Upper Airway in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Concomitant Obstructive Sleep Apnea (OSA)

The purpose of study is to evaluate the physiologic effects of pulmonary tissue/structural changes associated with COPD and upper airway inflammation on upper airway collapsibility. Upper airway collapsibility is closely associated with development of obstructive sleep apnea (OSA), which is a common disease characterized by repetitive collapse of upper airway during sleep, leading to hypoxemia and arousal. OSA has important neurocognitive and cardiovascular consequences, especially in patients with COPD.

Participants in this research study will undergo two overnight sleep studies (PSGs), pulmonary function test, and CT scan of the upper airway and chest. The first sleep study will evaluate the sleep breathing disorder and the second sleep study will measure the upper airway collapsibility, called critical closing pressure (Pcrit). Pcrit is measured by a modified continuous positive airway pressure (CPAP) machine which can provide a wide range of pressures between 20 and -20 cmH2O in order to modify upper airway pressure.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a physiologic study to assess the effects of lower airway and lung tissue changes of COPD on upper airway collapsibility. Increased in lung volume and destruction of alveolar wall in COPD may have opposite and various effects on the upper airway collapsibility, which is an important factor of OSA development.

Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) are very common disorders associated with considerable morbidity, mortality, and healthcare costs. The prevalence of both co-existing conditions is estimated to be ~4% of the general population. This COPD-OSA "overlap" syndrome causes more severe hypoxemia than either COPD or OSA alone and has important clinical consequences, including death. COPD is usually excluded in OSA research and OSA is typically excluded or not assessed in studies of COPD; thus, available information about the "overlap" syndrome is limited. Therefore, it is important to identify patients with both COPD and OSA and determine the mechanisms of poor outcomes for these patients in order to optimize therapy. The pathophysiology of the COPD-OSA syndrome is not well understood. The investigators propose to investigate upper airway (UA) anatomic characteristics and collapsibility as potential underlying mechanisms that may help to explain the negative additive effect of having both conditions. The objectives are to study CT measures of airway anatomy and the critical closing pressure of the upper airway (Pcrit), a gold standard measure of upper airway collapsibility, in patients with COPD-OSA compared with COPD only and normal controls. CT scan of upper airway and chest will allow precise measures of upper airway characteristics and COPD associated alveolar and lower airway ch. angesMeasures of upper airway collapsibility will provide us information about the mechanical nature of the airway and if the patients are more likely to have OSA. Subjects with COPD-OSA may exhibit more upper airway inflammation possibly due to their pre-existing COPD disease and the reoccurring opening and closing of the upper airway due to the OSA. Therefore the investigators would like to assess the degree of inflammation in these patients compared to normal controls.

Tipo de estudio

Intervencionista

Inscripción (Actual)

24

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • San Diego, California, Estados Unidos, 92093
        • University of California, San Diego

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria for COPD Subjects:

  • Age range 40-70 years.
  • Demonstrated moderate to severe COPD as determined by spirometry (post-bronchodilator spirometry FEV1/FVC < 0.70 for diagnosing CODP and FEV1<80% predicted for staging)
  • Smoking history of ≥ 10 pack-years

Inclusion Criteria for Control Subjects

  • Age range 40-70 years
  • Demonstrated no COPD as determined by normal spirometry (post-bronchodilator spirometry FEV1/FVC > 0.70 for diagnosing CODP and FEV1<80% predicted for staging)
  • No smoking history as defined by less than 100 cigarettes smoked in a lifetime

Exclusion Criteria for both COPD and Control Subjects:

  • Metal objects that may interfere with chest CT quantification including presence of a cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile or metal weapon fragment (bullet, shrapnel, shotgun shot) or metal shoulder prosthesis

  • Subjects unable to perform spirometry due to:

    • chest or abdominal surgery in the past three months
    • a heart attack in the last three months
    • detached retina or eye surgery in the past three months
    • hospitalization for any other heart problem in the past month
  • History of hypersensitivity to Afrin, Lidocaine or albuterol
  • A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
  • More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day
  • Pregnancy or suspected pregnancy

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: COPD Group
Patients who were previously diagnosed of moderate to severe COPD as determined by spirometry. All patients will have sleep and pulmonary physiologic measurements.
Otro: Sleep and pulmonary physiologic measurements
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage
Comparador activo: Normal Control Group
Patients who are healthy, without major medical or sleep problems, and have normal spirometry. All patients will have sleep and pulmonary physiologic measurements.
Otro: Sleep and pulmonary physiologic measurements
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Critical closing pressure (PCrit)
Periodo de tiempo: Baseline
Measured during overnight sleep study
Baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pharyngeal lavage cell count distribution
Periodo de tiempo: Baseline
Baseline
Minimal later airway dimension (mLAT)
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Minimal anteroposterior airway dimension (mAP)
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Minimal cross sectional airway area (mCSA)
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Lateral airway dimension on hard palate/uvula/epiglottis level
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Anteroposterior airway dimension on hard palate/uvula/epiglottis level
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Cross-sectional airway area on hard palate/uvula/epiglottis level
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Distance between the lower edge of the mandible and the lower edge of the hyoid (MH)
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Upper airway length
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Width of hard palate
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Nasophayngeal/retropalatal/retroglossal pharyngeal cavity volume
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Volume within the cervico-mandibular bony frame
Periodo de tiempo: Baseline
Measured from upper airway CT scan
Baseline
Volume of retropalatal/retroglossal soft tissue
Periodo de tiempo: Baseline
Baseline
Parapharyngeal fat pad volume
Periodo de tiempo: Baseline
Baseline
Tongue volume
Periodo de tiempo: Baseline
Baseline
Emphysema score
Periodo de tiempo: Baseline
Measured from CT chest scan
Baseline
Emphysema distribution
Periodo de tiempo: Baseline
Measured from CT chest scan
Baseline
Lower airway wall thickness on chest CT scan
Periodo de tiempo: Baseline
Measured from CT chest scan
Baseline
Forced expiratory volume in 1 second (FEV1)
Periodo de tiempo: Baseline
Baseline
Total lung capacity (TLC)
Periodo de tiempo: Baseline
Baseline
Ratio of residual volume / total lung capacity (RV/TLC)
Periodo de tiempo: Baseline
Baseline
Diffusing capacity of the lung for carbon monoxide (DLCO)
Periodo de tiempo: Baseline
Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of California, San Diego

Investigadores

  • Investigador principal: Xavier Soler, MD, PhD, University of California, San Diego

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de julio de 2015

Finalización primaria (Actual)

11 de agosto de 2016

Finalización del estudio (Actual)

11 de agosto de 2016

Fechas de registro del estudio

Enviado por primera vez

27 de septiembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

1 de octubre de 2015

Publicado por primera vez (Estimar)

5 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de mayo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2020

Última verificación

1 de mayo de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UCSD130851

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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