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NCT04786184Completed

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

Source: ClinicalTrials.gov · Last updated 3 Jul 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
42 (actual)
First submitted
4 Mar 2021
Start date
1 Oct 2021
Primary completion date
14 Jul 2023
Lead sponsor
Columbia University
Diseases
COPD
NCT number
NCT04786184

What you commit to

  • Study type: Interventional
  • Participants enrolled: 42
  • From 1 Oct 2021 to the primary completion date, 14 Jul 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • are actively being treated for cancer
  • 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
  • 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 a diagnosis or medical history of schizophrenia, psychotic disorders, or bipolar disorder as diagnosed by study psychologist
  • 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.

Other

  • are not eligible for pulmonary rehabilitation
  • have morbid obesity (Body Mass Index (BMI) \> 40)
  • have hypercapnia of ETCO2 \> 50 mmHg at rest
  • reside in an acute hospital, sub-acute care, assisted living, or nursing home
  • are active smokers
  • are pregnant
  • 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 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Columbia University Irving Medical Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
New York University Grossman School of Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.