Clinical trial NCT03457103: Capnometry-Assisted Breathing Training for COPD
Official title: Capnometry-Assisted Breathing Training for COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Capnometry-Assisted Breathing Training for COPD (CATCH) is a behavioral intervention that aims to promote optimal, self-regulated, mindful breathing. A portable capnometer is used in-session to provide continuous visual feedback of Respiratory Rate (RR), End-Tidal Carbon Dioxide Tension (ETCO2), and breathing pattern. The tailored CATCH intervention will emphasize a slow, quiet, regular, nasal breathing pattern, as well as pursed lips breathing (PLB). CATCH is once weekly for 6 weeks, for a total of 6 sessions; each session is approximately 60 minutes long. The principal investigator will implement the CATCH intervention. The principal investigator will implement the CATCH intervention. Patients will use the Address Stress app on a smart phone or computer tablet as part of their home breathing exercises.


Eligibility criteria: Inclusion Criteria:

* over 40 years of age
* has COPD documented in their electronic medical record, as defined by FEV1/FVC of \< 0.70 on pulmonary function testing (spirometry), or as shown on a chest CT
* Can maintain oxygen saturation (SaO2) ≥ 90% on room air at rest
* Is medically cleared to participate in NYULMC's outpatient pulmonary rehabilitation program
* English speaking. Pregnant patients will not be enrolled in the study

Exclusion Criteria:

* Requires 24-hour supplemental oxygen
* Has cognitive impairment as measured by ≤23/30 on the Mini Mental State Examination (MMSE)
* Is actively being treated for lung cancer (E.g. with chemotherapy or upcoming surgery)
* Has morbid obesity (BMI \> 40)
* Is currently smoking
* Has unstable cardiac disease defined by a history of a myocardial infarction in the past 3 months

Primary outcomes:
measure: Number of Participants With Adherence to Home Breathing Exercises
timeFrame: Day 1
Secondary outcomes:
measure: Difference in Mean 6MWT Distance Between Pre and Post Intervention
timeFrame: Week 0 and Week 10
measure: Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention
timeFrame: 2 weeks pre intervention and 4 weeks post intervention
measure: Mean Difference in Heart Rate Maximum Between Pre and Post Intervention
timeFrame: 0 weeks and 10 weeks
measure: Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention
timeFrame: 0 weeks and 10 weeks
measure: Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention
timeFrame: 0 weeks and 10 weeks
measure: Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention
timeFrame: Week 0 and Week 10
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Anna Maria Norweg, MD
role: STUDY_DIRECTOR
References: