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COPD-Related Physiology and the Brain

NCT ID: NCT03269721

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2025-04-30

Brief Summary

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COPD is the third leading cause of combined morbidity, disability, and mortality in the United States and is often associated with cognitive impairment. The goal of the proposed project is to examine novel pulmonary and vascular physiological mechanisms that contribute to structural brain abnormalities and cognitive dysfunction early in the course of COPD. The project will generate information to ultimately inform the development of interventions to delay or prevent cognitive dysfunction.

Detailed Description

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Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of morbidity and mortality in the US with increasing prevalence in older adults. The impact of COPD on the brain is an area of expanding research interest. A staggering 40-60% of patients with COPD have cognitive impairments including deficits in executive functioning (e.g., decision making), processing speed, and memory. Intact cognition is critical for independently managing daily tasks (e.g., medication and money management). Since there are currently no treatments to fully reverse cognitive impairment once it is present, preventing and delaying onset is essential. Given the high prevalence of COPD, understanding how COPD confers an increased risk for cognitive impairment should be a top public health priority. There is an urgent need to identify potentially modifiable physiological characteristics of individuals with early COPD-related pathophysiology who are at risk of developing brain abnormalities. The earliest changes that occur in COPD are driven by an enhanced chronic inflammatory response that includes small airway disease in the lung and vascular abnormalities. COPD-related lung pathophysiology can be measured continuously and is separable from amount of smoking. These physiological changes are often present in individuals who do not meet traditional criteria for COPD diagnosis and have not yet manifested significant clinical symptoms. We propose that chronic smokers who are susceptible to COPD and show evidence of COPD-related lung pathophysiology on lung CT also experience vascular dysfunction (particularly central artery stiffness) that contributes to structural brain abnormalities and cognitive impairment. The proposed project will: 1) model the effects of novel physiological mechanisms on the brain in COPD, 2) focus on changes in brain structure and function early in the development of COPD by including smokers who have evidence of early COPD-related lung pathophysiology but do not meet traditional criteria for COPD, and 3) utilize advanced technology to assess the lung (lung CT) and brain (MRI). We will recruit participants with existing lung CT from ongoing NIH projects to complete pulmonary and vascular measures, cognitive assessment, and brain MRI. The project is highly multidisciplinary and leverages unique resources at the University of Iowa including the Institute for Clinical and Translational Science, the Translational Human Vascular Physiology Lab, the Iowa Neuroimaging Consortium, and the Iowa Comprehensive Lung Imaging Center.

Conditions

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Pulmonary Disease, Chronic Obstructive (COPD) Cognitive Impairment

Keywords

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Cognition Pulmonary COPD Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Never Smoker

Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI

Neuropsychological Assessment

Intervention Type BEHAVIORAL

Assessments include: Paper and pencil computerized measures of Memory, Language, Visuospatial Function, Executive Functioning-Processing Speed, and Attention

Spirometry

Intervention Type PROCEDURE

Pre and post bronchodilator spirometry will be administered according to the American Thoracic Society (ATS) guidelines.

Arterial Blood Gas

Intervention Type PROCEDURE

Radial artery blood sample will be collected to measure gas exchange hemoglobin; arterial oxygen and carbon dioxide will be examined as potential covariates.

Diffusion Capacity of the Lung for Carbon Monoxide

Intervention Type PROCEDURE

For measurement of gas exchange in the lung. DLCO adjusted for hemoglobin will be the primary variable of interest and will be examined as a potential covariate.

6 Minute Walk Test

Intervention Type DIAGNOSTIC_TEST

Distance walked in 6 minutes will be the primary outcome.

Systemic Vascular Measures

Intervention Type PROCEDURE

Carotid artery ultrasound, pulse wave velocity, brachial artery endothelium-dependent flow mediated dilation and endothelium-independent dilation will be measured.

Blood Biomarkers

Intervention Type BIOLOGICAL

High sensitivity C-reactive protein (hs-CRP), and fibrinogen will be used as indicators of systemic inflammation, complete blood count with differential (CBC with diff) will be obtained to rule out acute infection as a cause of inflammation.

Symptom Questionnaire Measures

Intervention Type BEHAVIORAL

M.I.N.I Screen 7.0.0, Beck Depression Inventory-II (DBI-II), State Trait Anxiety Inventory (STAI), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), MMRC Dyspnea Scale (MMRC), Berlin Questionnaire

Brain MRI

Intervention Type PROCEDURE

Primary neuroimaging outcomes of interest are white matter structural integrity

Smoker/Past smoker-No Airflow Limitation

Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI

Neuropsychological Assessment

Intervention Type BEHAVIORAL

Assessments include: Paper and pencil computerized measures of Memory, Language, Visuospatial Function, Executive Functioning-Processing Speed, and Attention

Spirometry

Intervention Type PROCEDURE

Pre and post bronchodilator spirometry will be administered according to the American Thoracic Society (ATS) guidelines.

Arterial Blood Gas

Intervention Type PROCEDURE

Radial artery blood sample will be collected to measure gas exchange hemoglobin; arterial oxygen and carbon dioxide will be examined as potential covariates.

Diffusion Capacity of the Lung for Carbon Monoxide

Intervention Type PROCEDURE

For measurement of gas exchange in the lung. DLCO adjusted for hemoglobin will be the primary variable of interest and will be examined as a potential covariate.

6 Minute Walk Test

Intervention Type DIAGNOSTIC_TEST

Distance walked in 6 minutes will be the primary outcome.

Systemic Vascular Measures

Intervention Type PROCEDURE

Carotid artery ultrasound, pulse wave velocity, brachial artery endothelium-dependent flow mediated dilation and endothelium-independent dilation will be measured.

Blood Biomarkers

Intervention Type BIOLOGICAL

High sensitivity C-reactive protein (hs-CRP), and fibrinogen will be used as indicators of systemic inflammation, complete blood count with differential (CBC with diff) will be obtained to rule out acute infection as a cause of inflammation.

Symptom Questionnaire Measures

Intervention Type BEHAVIORAL

M.I.N.I Screen 7.0.0, Beck Depression Inventory-II (DBI-II), State Trait Anxiety Inventory (STAI), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), MMRC Dyspnea Scale (MMRC), Berlin Questionnaire

Brain MRI

Intervention Type PROCEDURE

Primary neuroimaging outcomes of interest are white matter structural integrity

Smoker/Past smoker-W/Airflow Limitation

Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI

Neuropsychological Assessment

Intervention Type BEHAVIORAL

Assessments include: Paper and pencil computerized measures of Memory, Language, Visuospatial Function, Executive Functioning-Processing Speed, and Attention

Spirometry

Intervention Type PROCEDURE

Pre and post bronchodilator spirometry will be administered according to the American Thoracic Society (ATS) guidelines.

Arterial Blood Gas

Intervention Type PROCEDURE

Radial artery blood sample will be collected to measure gas exchange hemoglobin; arterial oxygen and carbon dioxide will be examined as potential covariates.

Diffusion Capacity of the Lung for Carbon Monoxide

Intervention Type PROCEDURE

For measurement of gas exchange in the lung. DLCO adjusted for hemoglobin will be the primary variable of interest and will be examined as a potential covariate.

6 Minute Walk Test

Intervention Type DIAGNOSTIC_TEST

Distance walked in 6 minutes will be the primary outcome.

Systemic Vascular Measures

Intervention Type PROCEDURE

Carotid artery ultrasound, pulse wave velocity, brachial artery endothelium-dependent flow mediated dilation and endothelium-independent dilation will be measured.

Blood Biomarkers

Intervention Type BIOLOGICAL

High sensitivity C-reactive protein (hs-CRP), and fibrinogen will be used as indicators of systemic inflammation, complete blood count with differential (CBC with diff) will be obtained to rule out acute infection as a cause of inflammation.

Symptom Questionnaire Measures

Intervention Type BEHAVIORAL

M.I.N.I Screen 7.0.0, Beck Depression Inventory-II (DBI-II), State Trait Anxiety Inventory (STAI), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), MMRC Dyspnea Scale (MMRC), Berlin Questionnaire

Brain MRI

Intervention Type PROCEDURE

Primary neuroimaging outcomes of interest are white matter structural integrity

Interventions

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Neuropsychological Assessment

Assessments include: Paper and pencil computerized measures of Memory, Language, Visuospatial Function, Executive Functioning-Processing Speed, and Attention

Intervention Type BEHAVIORAL

Spirometry

Pre and post bronchodilator spirometry will be administered according to the American Thoracic Society (ATS) guidelines.

Intervention Type PROCEDURE

Arterial Blood Gas

Radial artery blood sample will be collected to measure gas exchange hemoglobin; arterial oxygen and carbon dioxide will be examined as potential covariates.

Intervention Type PROCEDURE

Diffusion Capacity of the Lung for Carbon Monoxide

For measurement of gas exchange in the lung. DLCO adjusted for hemoglobin will be the primary variable of interest and will be examined as a potential covariate.

Intervention Type PROCEDURE

6 Minute Walk Test

Distance walked in 6 minutes will be the primary outcome.

Intervention Type DIAGNOSTIC_TEST

Systemic Vascular Measures

Carotid artery ultrasound, pulse wave velocity, brachial artery endothelium-dependent flow mediated dilation and endothelium-independent dilation will be measured.

Intervention Type PROCEDURE

Blood Biomarkers

High sensitivity C-reactive protein (hs-CRP), and fibrinogen will be used as indicators of systemic inflammation, complete blood count with differential (CBC with diff) will be obtained to rule out acute infection as a cause of inflammation.

Intervention Type BIOLOGICAL

Symptom Questionnaire Measures

M.I.N.I Screen 7.0.0, Beck Depression Inventory-II (DBI-II), State Trait Anxiety Inventory (STAI), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), MMRC Dyspnea Scale (MMRC), Berlin Questionnaire

Intervention Type BEHAVIORAL

Brain MRI

Primary neuroimaging outcomes of interest are white matter structural integrity

Intervention Type PROCEDURE

Other Intervention Names

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(DLCO) 6MWT

Eligibility Criteria

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Inclusion Criteria

Age 30-85, \> 8th grade education, Normal/corrected hearing and vision, English Speaker, Ability to comfortably lie flat for 1 hour.

Exclusion Criteria

Other concomitant respiratory disorder other than asthma (e.g., cystic fibrosis), Use of antibiotics or steroids for a COPD exacerbation within the past month, Use of 24-hour oxygen, Pregnancy or suspected pregnancy, Uncontrolled cancer within the last 5 years, Radiation therapy to the chest, Lung surgery (LVRS, transplant, lobectomy), Lung cancer known or suspected, Eye surgery in the last 3 months, Pulmonary Hypertension, Insulin-dependent diabetes, Inability to use albuterol, Chest or abdominal surgery in the past 3 months, Heart attack in the last 3 months, Hospitalization for any heart problem in the past month, Prior neurological condition (e.g., stroke, epilepsy, head injury with \>15 mins. loss of consciousness), Previous diagnosis of dementia or learning disability, Major comorbid medical conditions with known cognitive effects (e.g., renal failure, HF), Psychotic disorder, bipolar disorder, current substance use disorder other than tobacco use, Change in psychiatric medication in last month, Claustrophobia, Metal object in body that may interfere with neuroimaging.
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Karin Hoth

OTHER

Sponsor Role lead

Responsible Party

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Karin Hoth

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karin F Hoth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa Department of Psychiatry

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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1R01HL134822-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201404738

Identifier Type: -

Identifier Source: org_study_id