Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385301
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-17
Brief Title:
Exercise Performance on Ambient Air vs Low-Flow Oxygen Therapy With Chronic Lung Diseases
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Exercise Performance on Ambient Air vs Commonly Prescribed Nasal Low Oxygen Therapy - a Non-Inferiority Trial in Patients With Exercise Induced Desaturation Due to Chronic Lung Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise
Detailed Description:
Participants with lung disease who live in Switzerland will have 6-minute walk distance 6MWD test with and without SOT at approximately 3lmin via nasal cannula according to a randomized cross-over design
The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air
Our effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air
The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air
Our effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air
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