Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-01 @ 3:13 AM
Study NCT ID:
NCT06404008
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2024-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Controlled Breathing Intervention to Reduce Stress and Improve Symptoms in COPD Patients (REST)
Sponsor:
University of Texas at Austin
Organization:
Study Overview
Official Title:
A Controlled Breathing Intervention to Reduce Stress and Improve Symptoms in COPD Patients (REST): A Randomized Pilot Trial
Status:
COMPLETED
Status Verified Date:
2025-11
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:
REST
Brief Summary:
This is a parallel design, randomized, controlled pilot trial comparing a controlled breath intervention (REST) to usual care for reducing stress in individuals with COPD.
Detailed Description:
This is a parallel design, randomized, controlled pilot trial comparing a controlled breath intervention (REST) to usual care for reducing stress in individuals with chronic obstructive pulmonary disease (COPD). The intervention is based on the breathing techniques of Pranayama. It was developed with patient and stakeholder input and is targeted for individuals with COPD who have moderate levels of stress and symptom burden. The intervention is a 15-minute breathing protocol which will be taught to participants and subsequently evaluated in a clinic setting with surveys, lung function, and cardiac assessments. This intervention will be pre-tested in 6 individuals, revised, and piloted in 30 individuals (15 in intervention group, 15 in control group). This study will answer the question of 1) whether a controlled breath protocol is feasible, acceptable, and safe for patients with COPD and 2) whether any modifications to the intervention are needed for a future multicenter trial to be proposed and conducted after the completion of the pilot trial. We will also 3) obtain sufficient estimates of variability in stress measures to inform statistical planning of a future trial.
Study Oversight
Has Oversight DMC:
False
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?: