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

5 mai 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

24

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • San Diego, California, États-Unis, 92093
        • University of California, San Diego

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Autre: Sleep and pulmonary physiologic measurements
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage
Comparateur actif: 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.
Autre: Sleep and pulmonary physiologic measurements
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Critical closing pressure (PCrit)
Délai: Baseline
Measured during overnight sleep study
Baseline

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of California, San Diego

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juillet 2015

Achèvement primaire (Réel)

11 août 2016

Achèvement de l'étude (Réel)

11 août 2016

Dates d'inscription aux études

Première soumission

27 septembre 2015

Première soumission répondant aux critères de contrôle qualité

1 octobre 2015

Première publication (Estimation)

5 octobre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 mai 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 mai 2020

Dernière vérification

1 mai 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • UCSD130851

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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