Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure

NCT07047092 | Not Yet Recruiting Phase 3

• 1 other identifier: NOCOCA
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation; Obstructive Sleep Apnea Exacerbation

Keywords

Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea; Continuous Positive Airway Pressure; Non-invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Demonstrate the superiority of home NIV versus home CPAP for the reduction of severe exacerbation of COPD or death.

  Reduction of severe exacerbation of COPD or death, defined by the time to occurrence of (i) death from any cause or (ii) hospitalization in relation to severe exacerbation of COPD during a follow up of 12 months after randomization.

  0-12 months from inclusion

Secondary Outcomes (18)

• Evaluate the benefit of NIV over CPAP regarding control of sleep disordered breathing

  0-12 months from inclusion

• Quality of life of NIV over CPAP

  At month 3

• Quality of life of NIV over CPAP

  At month 12

• Quality of sleep of NIV over CPAP (Pittsburgh Sleep Quality Index).

  From Day 1 to Day 90

• Quality of sleep of NIV over CPAP

  From Day 1 to Day 90

Study Arms (2)

Non-invasive Ventilation (NIV)

EXPERIMENTAL

Patients randomised to the intervention arm will be established on NIV before discharge to home.

Device: Non-invasive Ventilation (NIV)

Continuous Positive Airway Pressure (CPAP)

ACTIVE COMPARATOR

Patients randomised to the control arm will be established on CPAP before discharge to home.

Device: Continous Positive Airway Pressure (CPAP)

Interventions

Non-invasive Ventilation (NIV) DEVICE

Patients will receive a dedicated training for the use of their NIV in the home setting. The training is the same provided in the usual care of patients established on NIV. They will choose a home care provider for the delivery of NIV as per standard care in France. A telemonitoring of adherence to NIV will be performed.

Non-invasive Ventilation (NIV)

Continous Positive Airway Pressure (CPAP) DEVICE

Patients will receive a dedicated training the use of their CPAP in the home setting. The training is the same provided in the usual care of patients established on CPAP. They will choose a home care provider for the delivery of CPAP as per standard care in France. Follow-up of CPAP will be performed according to standard care in France and will therefore include a telemonitoring of adherence to CPAP.

Continuous Positive Airway Pressure (CPAP)

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and \< 85 years
• Patient with a diagnosis of COPD according to GOLD guidelines
• Patient admitted for an acute exacerbation of COPD requiring acute NIV or invasive ventilation or high-flow therapy (pH \<7.35 with PaCO2 \>45mmHg/6kPa)
• Patient that has been weaned from acute NIV or invasive ventilation or high flow therapy
• Patient with an overnight polygraphy or polysomnography performed 2 to 30 days following weaning from acute NIV or invasive ventilation showing an obstructive apneahypopnea index \>=15/h. For patients already diagnosed with OSA, results from their prior sleep study will be retrieved. If not accessible, overnight polygraphy or polysomnography will be repeated.
• Affiliated to the National Health Patients affiliated or, beneficiary of social security, excluding AME (Aide Médicale d'État)
• Patient who has read and understood the information letter and signed the consent form

You may not qualify if:

• Patient with NIV treatment
• Patients who decline any use of NIV or CPAP in the home setting
• Significant psychiatric disorder or dementia that would prevent adherence to study protocol
• Tobacco use \<10 pack-year
• Expected survival \<12 months due to any condition other than COPD.
• Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
• Pregnant or breastfeeding women
• Patient already involved in an interventional research protocol that would impact the outcome measured in the current protocol.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Pitié-Salpêtrière - Sleep unit, R3S Departement

Paris, 75013, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Maxime PATOUT, MD, PhD

CONTACT

01 42 16 77 09; maxime.patout@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Clinical experts in charge of assessing whether a hospitalization was caused by a COPD exacerbation will blinded to the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 2, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

FR (1)