Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-20 @ 12:46 PM
Study NCT ID:
NCT07047092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
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:
None
Brief Summary:
Chronic obstructive pulmonary disease (COPD) is a major public health problem with 212.3 million prevalent cases of COPD worldwide and 3.3 million deaths related to COPD in 2019. Obstructive sleep apnoea (OSA) is the most common sleep disordered breathing. It is estimated that almost 1 billion adults have OSA worldwide.
Given the increasing prevalence of obesity, co-morbid OSA is frequently seen in patients with COPD. Co-morbid OSA has been shown to increase mortality, to reduce quality of life and to favour acute exacerbation of COPD. For those admitted for a life-threatening exacerbation of COPD requiring an intensive care admission for acute hypercapnic failure, they are more likely to get readmitted. For those admitted for an acute exacerbation in any ward, they are more likely to be re-admitted for another exacerbation within 180-days if their OSA is not treated.
Unfortunately, data regarding the best management of OSA in patients with co-morbid COPD are lacking as they were often excluded from clinical trials involving patients with COPD. Therefore, CPAP or NIV are administered without scientific evidence establishing which treatment is the most appropriate.
Given the increasing prevalence of obesity, co-morbid OSA is frequently seen in patients with COPD. Co-morbid OSA has been shown to increase mortality, to reduce quality of life and to favour acute exacerbation of COPD. For those admitted for a life-threatening exacerbation of COPD requiring an intensive care admission for acute hypercapnic failure, they are more likely to get readmitted. For those admitted for an acute exacerbation in any ward, they are more likely to be re-admitted for another exacerbation within 180-days if their OSA is not treated.
Unfortunately, data regarding the best management of OSA in patients with co-morbid COPD are lacking as they were often excluded from clinical trials involving patients with COPD. Therefore, CPAP or NIV are administered without scientific evidence establishing which treatment is the most appropriate.
Detailed Description:
Patients admitted for a severe exacerbation of COPD that required NIV or invasive ventilation or high flow therapy will be screened for the trial once they reach clinical stability that allow weaning of NIV, invasive ventilation, or high flow therapy.
The screening visit will take place during a standard consultation between 2 days following admission for acute hypercapnic respiratory failure and no later than 30 days following the discharge from the acute ward.
The inclusion visit will be performed no later than 30-days following discharge from the acute ward.
Follow-up visits will be performed at 3, 6 months after inclusion with a +/-14 days window.
Visits will be conducted in the hospital unless patient is unable to attend due to medical condition or healthcare crisis (infectious pandemic for example). In that case, a remote consultation will be performed to retrieve data available without physical attendance.
The screening visit will take place during a standard consultation between 2 days following admission for acute hypercapnic respiratory failure and no later than 30 days following the discharge from the acute ward.
The inclusion visit will be performed no later than 30-days following discharge from the acute ward.
Follow-up visits will be performed at 3, 6 months after inclusion with a +/-14 days window.
Visits will be conducted in the hospital unless patient is unable to attend due to medical condition or healthcare crisis (infectious pandemic for example). In that case, a remote consultation will be performed to retrieve data available without physical attendance.
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?: