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

5. maj 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Diego, California, Forenede Stater, 92093
        • University of California, San Diego

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Andet: Sleep and pulmonary physiologic measurements
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage
Aktiv komparator: 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.
Andet: Sleep and pulmonary physiologic measurements
Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Critical closing pressure (PCrit)
Tidsramme: Baseline
Measured during overnight sleep study
Baseline

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Diego

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2015

Primær færdiggørelse (Faktiske)

11. august 2016

Studieafslutning (Faktiske)

11. august 2016

Datoer for studieregistrering

Først indsendt

27. september 2015

Først indsendt, der opfyldte QC-kriterier

1. oktober 2015

Først opslået (Skøn)

5. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UCSD130851

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med Sleep and pulmonary physiologic measurements

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