Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD

Completed · Not applicable

Conditions studied: COPD

In brief

This pilot study is part of a phased approach to refine, optimize, and test the feasibility of CALM Breathing. Preliminary participant feedback from the Capnography-Assisted Respiratory Therapy (CART) study was applied to adapt and design CALM Breathing (including its dose, schedule, delivery, and home program). This pilot builds on initial lessons learned and identifies intervention areas still needing greater development to assure the success of a future large trial, targeting a subpopulation at risk, that is, those with COPD and anxiety sensitivity.

Key facts

Study ID

NCT04786184

Run by

Columbia University

People needed

42

Starts

2021-10-01

Expected to finish

2023-11-30

Last updated by the study team

2024-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• be adult males or females
• have a diagnosis of COPD as defined by FEV1/FVC of < 0.70 on spirometry testing or as shown on a chest computed tomography (CT)
• receive standard care of pharmacotherapy with bronchodilators (e.g. long-acting beta-agonists, LABAs, or long-acting muscarinic antagonists, or LAMAs) as prescribed by their physician
• are in stable medical condition as determined by pulmonary rehabilitation physician (i.e., not in need of acute higher level of care such as hospitalization)
• have dyspnea [as documented in their medical record or based on self-report; e.g., ≥1 on modified Medical Research Council questionnaire (mMRC) dyspnea; or ≥2 dyspnea score on item: "Over the last 4 weeks, I have had shortness of breath: almost every day = 4, several days a week = 3, a few days a month = 2, only with lung/respiratory infections = 1, not at all = 0; or "yes" response of binary presence of dyspnea-related avoidance of activities: "Have you avoided any activities due to shortness of breath?")]
• have elevated dyspnea-related anxiety symptoms:
• DMQ-CAT dyspnea anxiety score ≤50; or
• DMQ-CAT activity avoidance ≤50;
• VAS dyspnea anxiety scale score of ≥20, administered with 6-minute walk test;
• ASI-16: item #10, "It scares me when I become short of breath (at least "some");
• require ≤ 24 hours per day of supplemental oxygen
• Mini-Mental State Examination score ≥24
• speak, read, and write English
• are stably medicated for at least 4 weeks prior to study entry with long-acting anti-anxiety medication (e.g., selective serotonin reuptake inhibitors, SSRIs, and serotonin norepinephrine reuptake inhibitors, SNRIs), benzodiazepines, or cannabis if prescribed, with no plans to change psychotropic medication dose
• have not received any pulmonary rehabilitation training in the past 12 months.

You may not qualify if…

• are not eligible for pulmonary rehabilitation
• are actively being treated for cancer
• have morbid obesity (Body Mass Index (BMI) > 40)
• have hypercapnia of ETCO2 > 50 mmHg at rest
• have a musculoskeletal disorder severe enough to interfere with walking or ability to exercise or have neuromuscular disease
• have had a seizure in the past 3 months
• reside in an acute hospital, sub-acute care, assisted living, or nursing home
• are active smokers
• are pregnant
• have any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening, which in the opinion of the investigator may put the patient at risk or interfere with study assessments
• have low literacy as indicated by scores of 4 or 5 ("often" and "always") on the Single Item Literacy Screener (SILS) that asks, "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?"
• have a diagnosis or medical history of schizophrenia, psychotic disorders, or bipolar disorder as diagnosed by study psychologist
• have alcohol or substance abuse or dependence within the past 6 months as evaluated by study psychologist
• have serious suicidal risk (suicidal ideation or suicidal behaviors within the past year) as defined by a score of >1 on psychologist interview-administered Clinician Suicide Assessment Checklist, which is a Modified Columbia-Suicide Severity Rating Scale-CSSRS
• Take prescribed opioids ≥50 MME (morphine mg equivalents) per day. A dosage threshold of ≥50 MME significantly increases the risk of fatal respiratory depression and necessitates additional precautions. Participants' opioid medication dose will be confirmed by their prescribing physician (e.g., their primary care or pain management doctor).
• Actively take both prescribed opioids and benzodiazepines. Combining benzodiazepines and opioids significantly increases the risk of respiratory failure in patients with chronic obstructive pulmonary disease.

Where it is running

• New York University Grossman School of Medicine — New York, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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