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

5 mei 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

24

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • San Diego, California, Verenigde Staten, 92093
        • University of California, San Diego

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Ander: Sleep and pulmonary physiologic measurements
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage
Actieve vergelijker: 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.
Ander: Sleep and pulmonary physiologic measurements
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Critical closing pressure (PCrit)
Tijdsspanne: Baseline
Measured during overnight sleep study
Baseline

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Diego

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2015

Primaire voltooiing (Werkelijk)

11 augustus 2016

Studie voltooiing (Werkelijk)

11 augustus 2016

Studieregistratiedata

Eerst ingediend

27 september 2015

Eerst ingediend dat voldeed aan de QC-criteria

1 oktober 2015

Eerst geplaatst (Schatting)

5 oktober 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 mei 2020

Laatste update ingediend die voldeed aan QC-criteria

5 mei 2020

Laatst geverifieerd

1 mei 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UCSD130851

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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