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

NCT02567448 | Terminated

• 1 other identifier: UCSD130851
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease; Overlap syndrome; Pcrit; Critical closing pressure

Outcome Measures

Primary Outcomes (1)

• Critical closing pressure (PCrit)

  Measured during overnight sleep study

  Baseline

Secondary Outcomes (22)

• Pharyngeal lavage cell count distribution

  Baseline

• Minimal later airway dimension (mLAT)

  Baseline

• Minimal anteroposterior airway dimension (mAP)

  Baseline

• Minimal cross sectional airway area (mCSA)

  Baseline

• Lateral airway dimension on hard palate/uvula/epiglottis level

  Baseline

Study Arms (2)

COPD Group

ACTIVE COMPARATOR

Patients who were previously diagnosed of moderate to severe COPD as determined by spirometry. All patients will have sleep and pulmonary physiologic measurements.

Other: Sleep and pulmonary physiologic measurements

Normal Control Group

ACTIVE COMPARATOR

Patients who are healthy, without major medical or sleep problems, and have normal spirometry. All patients will have sleep and pulmonary physiologic measurements.

Other: Sleep and pulmonary physiologic measurements

Interventions

Sleep and pulmonary physiologic measurements OTHER

Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage

COPD Group; Normal Control Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Pulmonary Disease, Chronic Obstructive

Interventions

Sleep

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Xavier Soler, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 27, 2015
• First Posted: October 5, 2015
• Study Start: July 1, 2015
• Primary Completion: August 11, 2016
• Study Completion: August 11, 2016
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

US (1)