Adherence, Treatment Clinical Trial
Official title:
Impact of Nasal High Flow (NHF) Versus Home Non-invasive Ventilation (NIV) on Nocturnal Transcutaneous PCO2 (PtCO2) in Stable COPD Patients: A Non-inferiority Study
Monocentric, prospective, open, randomized 1:1, controlled study to evaluate the impact of nasal high-flow (NHF) on nocturnal transcutaneous PCO2 (PtCO2) compared to non-invasive ventilation ± Long-Term Oxygen Therapy (LTOT) in patients with a Chronic obstructive pulmonary disease (COPD)-related hypercapnic respiratory failure.
Chronic obstructive pulmonary disease (COPD) is a growing global health concern, causing considerable health-related costs and increased mortality. COPD is nowadays considered a complex, heterogeneous and systemic condition. In the late stage of the disease, non-invasive ventilation (NIV) is widely prescribed either to treat acute hypercapnic respiratory failure during COPD exacerbations or for long term home management. A meta-analysis has shown that higher daytime PaCO2 occurred in home NIV treated COPD patients when NIV compliance is less than 5 h/day. Thus, an optimal NIV adherence is a key target for controlling nocturnal and diurnal hypoventilation and improving prognosis. COPD is the clinical scenario during which a good NIV adherence is difficult to achieve. Particularly, in COPDs exhibiting hyperinflation, NIV can aggravate dynamic hyperinflation resulting in unrewarded inspiratory efforts, poor sleep and low NIV compliance. Alternatives to NIV are then desirable in this specific subgroup of hypercapnic COPD with poor adherence to NIV. During this trial, stable COPD patients treated by long term home Non-Invasive Ventilation (NIV) treatment following French national recommendations and exhibiting a NIV compliance of (less than 5 hours and more than 1 hour) per day in the last 3 months prior to inclusion will be randomized via a secure electronic website to either continue with their current NIV treatment or receive the nasal high flow (NHF) treatment delivered by myAirvo2 during 3 months Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched air at high flow rates through a nasal cannula. The main physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercapnia, an optimization in breathing patterns with a reduction of work of breathing. Nasal High-Flow (NHF) is delivered via a comfortable nasal interface and has demonstrated good treatment adherence. The investigators hypothesize that in COPD-related hypercapnic chronic respiratory failure with limited compliance to NIV (less than 5 hours per night), nasal High-Flow (NHF) will be non-inferior for controlling nocturnal hypoventilation and might improve daytime subjective patients centered outcomes, physical activity and nocturnal adherence to treatment. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06175299 -
Social Functions to Promote Home-based Cognitive Training
|
N/A | |
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Completed |
NCT04968041 -
KNA Proof-of-Concept
|
N/A | |
Recruiting |
NCT05385302 -
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
|
||
Not yet recruiting |
NCT05934968 -
Mad Dog Cooking Class Series: Effects on Dietary Self-efficacy, Eating Behaviors and Health Outcomes
|
N/A | |
Recruiting |
NCT06192446 -
Factors Influencing Adherence to Adjuvant Endocrine Therapy
|
||
Completed |
NCT05394883 -
The SPROUT (Pilot) Project
|
N/A | |
Not yet recruiting |
NCT05957861 -
Exploring the Effectiveness to Web-based Exercise Among Community-dwelling Adults With High Body Fat
|
N/A | |
Recruiting |
NCT05092074 -
Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection
|
||
Recruiting |
NCT05016856 -
Smart Reminders to Promote Home-based Cognitive Training
|
N/A | |
Recruiting |
NCT06030349 -
Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
|
||
Active, not recruiting |
NCT04228107 -
Treatment Phenotypes for Adolescents With Asthma
|
N/A | |
Completed |
NCT04160026 -
Acceptability and Feasibility in the Context of the IMPROVE Trial in Kenya
|
Phase 4 | |
Recruiting |
NCT06263296 -
Smartphone Assisted Self-management Education for Adult Burn Patient at Aftercare
|
N/A | |
Not yet recruiting |
NCT06364683 -
Coronary Artery Disease and Exercise Adherence
|
||
Recruiting |
NCT05433545 -
Adherence to Physiotherapy Scoliosis Specific Exercises in Adolescents With Spine Deformity: Development of a New Questionnaire
|
||
Recruiting |
NCT05613010 -
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
|
N/A | |
Recruiting |
NCT05787145 -
ComCancer: Use of Let's Discuss Health Website by Patients With Prostate Cancer Undergoing Radiation Oncology Treatment
|
N/A | |
Recruiting |
NCT06372548 -
Rehabilitation Training Games for Children With Amblyopia
|
N/A | |
Active, not recruiting |
NCT06038344 -
Influence of a Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Youth With Celiac Disease
|
N/A |