COPD-Related Physiology and the Brain

NCT03269721 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2025-12-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Neuropsychological Assessment

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

PROCEDURE

Spirometry

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

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.

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.

DIAGNOSTIC_TEST

6 Minute Walk Test

Distance walked in 6 minutes will be the primary outcome.

PROCEDURE

Systemic Vascular Measures

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

BIOLOGICAL

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.

BEHAVIORAL

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

PROCEDURE

Brain MRI

Primary neuroimaging outcomes of interest are white matter structural integrity

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • National Institutes of Health (NIH)

    collaborator NIH
  • Karin Hoth

    lead OTHER

Principal Investigators

  • Karin F Hoth, PhD · University of Iowa Department of Psychiatry

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03269721 on ClinicalTrials.gov