Capnometry-Assisted Breathing Training for COPD

NCT03457103 | Completed Phase 2 Results FDA Device

• 1 other identifier: 17-01672
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adherence to Home Breathing Exercises

  Day 1

Secondary Outcomes (6)

• Difference in Mean 6MWT Distance Between Pre and Post Intervention

  Week 0 and Week 10

• Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention

  2 weeks pre intervention and 4 weeks post intervention

• Mean Difference in Heart Rate Maximum Between Pre and Post Intervention

  0 weeks and 10 weeks

• Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention

  0 weeks and 10 weeks

• Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention

  0 weeks and 10 weeks

Study Arms (2)

CATCH Group

EXPERIMENTAL

A portable capnometer (CapnoTrainer, Better Physiology, Cheyenne, WY) will be used in-session to provide continuous visual feedback of RR, ETCO2, rhythm, and depth of breathing, and ratio of inspirations to expiration. CATCH will be once weekly for 6 weeks, for a total of 6 sessions; each session will be approximately 60 minutes duration. The principal investigator will implement the CATCH intervention

Device: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH); Device: Pulmonary Rehabilitation (PR)

Control Group

ACTIVE COMPARATOR

Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program.

Device: Pulmonary Rehabilitation (PR)

Interventions

Capnometry-Assisted Training for COPD to Slow the Breath (CATCH) DEVICE

Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.

CATCH Group

Pulmonary Rehabilitation (PR) DEVICE

Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).

CATCH Group; Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• Norweg AM, Wu Y, Troxel A, Whiteson JH, Collins E, Haas F, Skamai A, Goldring R, Jean-Louis G, Reibman J, Ehrlich-Jones L, Simon N. Mind-Body Intervention for Dysfunctional Breathing in Chronic Obstructive Pulmonary Disease: Feasibility Study and Lessons Learned. J Integr Complement Med. 2023 Mar;29(3):156-168. doi: 10.1089/jicm.2022.0552. Epub 2023 Feb 17.

  PMID: 36800224 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Anna Norweg
• Organization: NYU Langone

AnnaMaria.Norweg@nyulangone.org

646-501-7777

Study Officials

• Anna Maria Norweg, MD

  NYU Langone Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: June 16, 2015
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: August 18, 2021
• Results First Posted: August 18, 2021

Record last verified: 2021-07

Locations

US (1)