Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786184
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2021-03-04
Brief Title:
Capnography-Assisted Learned Monitored CALM Breathing Therapy for COPD
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Capnography-Assisted Learned Monitored CALM Breathing Therapy for COPD
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALM
Brief Summary:
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
Detailed Description:
The purpose of this study is to evaluate an experimental breathing therapy for adults with chronic obstructive pulmonary disease COPD called Capnography-Assisted Learned Monitored CALM Breathing CALM Breathing is an experimental therapy that uses exercises combined with breathing feedback CALM Breathing promotes self-regulated breathing to relieve symptoms In sessions biofeedback of breathing is predominately provided by two devices that are cleared by the Food and Drug Administration FDA to measure carbon dioxide at the end of a breath and breathing rate A capnograph uses tubing at the nose to evaluate levels of carbon dioxide and breathing rate from exhaled air and to display breathing patterns A pulse oximeter for home use also evaluates breathing rate at the fingertip with a sensor that detects blood flow changes The investigators are studying CALM Breathing to see if it can relieve shortness of breath and other symptoms reduce stress and improve quality of life and exercise tolerance in adults with COPD The investigators are planning to recruit up to approximately 65 subjects with COPD at Columbia University Irving Medical Center Participants will be assigned by chance into one of two treatment groups 1 CALM Breathing or Usual Care Waitlist Participants will have an equal chance of being assigned to either group CALM Breathing is a 4-week therapy program that uses breathing exercises with biofeedback to reduce shortness of breath and other symptoms related to COPD Biofeedback uses sensors to give information about breathing pattern and airflow to help participants better self-regulate their breathing Participants assigned by chance to CALM Breathing will participate in eight breathing therapy sessions provided twice per week each session will each take approximately 1-hour All participants will receive 16-20 standard care pulmonary rehabilitation sessions beginning at approximately week 6-10 Participants will complete three study evaluation visits at baseline 6 weeks and at a 3-month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-00751 | OTHER | None | None |
| R34AT010673 | NIH | NYU Langone Health | httpsreporternihgovquickSearchR34AT010673 |