Chronic Obstructive Pulmonary DiseasePhase 2CATCHNCT03457103
Capnometry-Assisted Breathing Training for COPD
A Phase 2 study testing Capnometry-Assisted Training for COPD to Slow the Breath (CATCH) and Pulmonary Rehabilitation (PR) in people with Chronic Obstructive Pulmonary Disease, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Capnometry-Assisted Training for COPD to Slow the Breath (CATCH) and Pulmonary Rehabilitation (PR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2015to 2 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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
- Being tested
- Capnometry-Assisted Training for COPD to Slow the Breath (CATCH), Pulmonary Rehabilitation (PR)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)Device
Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Pulmonary Rehabilitation (PR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adherence to Home Breathing Exercises
Measured: Day 1
Secondary outcomes (6)
Difference in Mean 6MWT Distance Between Pre and Post Intervention
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Measured: Week 0 and Week 10
Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention
The DMQ-CAT Dyspnea Anxiety is a 14 item scale; each item is scored off a 7 point likert scale for a total range of 0 to 98 where higher scores correlate with higher anxiety
Measured: 2 weeks pre intervention and 4 weeks post intervention
Mean Difference in Heart Rate Maximum Between Pre and Post Intervention
Measured: 0 weeks and 10 weeks
Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a questionnaire. Raw scores range from 7-35, with higher scores indicating higher levels of fatigue.
Measured: 0 weeks and 10 weeks
Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention
Measured: 0 weeks and 10 weeks
Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Week 0 and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start16 Jun 2015
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Maria Norweg, MD, Study director, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457103
- Sponsor's protocol ID
- 17-01672
- Acronym
- CATCH
- Status last verified
- Jul 2021
- First submitted
- 1 Mar 2018
- Last updated
- 18 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36800224
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capnometry-Assisted Breathing Training for COPD
- ClinicalTrials.gov ID
- NCT03457103
- Acronym / sponsor ID
- CATCH / 17-01672
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 Jun 2015 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Posted 18 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CATCH Group | Experimental | Device: Capnometry-Assisted Training for COPD to Slow the Breath (CATCH), Device: Pulmonary Rehabilitation (PR)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 |
| Control Group | Active comparator | Device: Pulmonary Rehabilitation (PR)Pulmonary Rehabilitation (PR). Patients in both treatment groups will participate in a 10-week (16 - 20 sessions) comprehensive PR program. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern. | Device | CATCH Group |
| Pulmonary Rehabilitation (PR)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). | Device | CATCH Group, Control Group |
Primary outcome
Number of Participants With Adherence to Home Breathing Exercises
Time frame: Day 1
6 secondary outcomes
Difference in Mean 6MWT Distance Between Pre and Post Intervention
Time frame: Week 0 and Week 10
Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention
Time frame: 2 weeks pre intervention and 4 weeks post intervention
Mean Difference in Heart Rate Maximum Between Pre and Post Intervention
Time frame: 0 weeks and 10 weeks
Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention
Time frame: 0 weeks and 10 weeks
Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention
Time frame: 0 weeks and 10 weeks
Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention
Time frame: Week 0 and Week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36800224Norweg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Maria Norweg, MD study director
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capnometry-Assisted Training for COPD to Slow the Breath (CATCH) and Pulmonary Rehabilitation (PR) in people with Chronic Obstructive Pulmonary Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adherence to Home Breathing Exercises (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03457103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.