Pathogenesis and Outcomes of Sleep Disordered Breathing in Chronic Obstructive Pulmonary Disease (COPD)
This research is being conducted to examine the effects of nasal insufflation of warm and humidified air through a small nasal cannula on sleep, breathing pulmonary function, and daytime exercise capability.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD|
- The evening to morning differences in expiratory airflow obstruction (FEV1/FVC) [ Time Frame: 4 years ] [ Designated as safety issue: No ]Lung function declines over the course of the night. We hypothesize that delivering warm and humidified air at a rate of 20 L/min over the entire night improves morning FEV1 compared to oxygen.
- The percent rate of inspiratory flow limitation. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]Patients with COPD often exhibit inspiratory air flow limitation during sleep. We hypothesize that delivering warm and humidified air at a rate of 20 L/min reduces the degree of inspiratory air flow limitation compared to oxygen.
- Effect of High flow nasal insufflation of air on exercise capacity (6 minute walk test). [ Time Frame: One Year ] [ Designated as safety issue: No ]Patients with COPD have impaired exercise tolerance in the morning. We hypothesize that delivering warm and humidified air at a rate of 20 L/min over the entire night extends morning 6 minute walk length.
- Sleep efficiency [ Time Frame: 4 years ] [ Designated as safety issue: No ]We hypothesize that delivering warm and humidified air at a rate of 20 L/min over the entire night improves sleep efficiency compared to oxygen treatment.
- Episodes of dynamic hyperinflation [ Time Frame: 4 years ] [ Designated as safety issue: No ]The combination of in- and expiratory flow limitation can lead to dynamic hyperinflation during sleep. We hypothesize that compared to oxygen, high flow nasal insufflation of warm and humidified air at a rate of 20 L/min will reduce the number of breaths associated with dynamic hyperinflation.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Active Comparator: oxygen
nocturnal oxygen of 2 L/min
oxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep.
Experimental: High Flow of room air
Warm and humidified air at a rate of 20 L/min through a small nasal cannula (similar to oxygen cannula)
Other: High flow of room air
Warm and humidified air at rates of 20 L/min will be delivered through a small nasal cannula throughout sleep
Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity including substantial daytime fatigue exertional intolerance and ventilatory impairment, which hits a nadir in the morning. Nocturnal disturbances in sleep and breathing are common in COPD, although the impact of these disturbances on COPD morbidity remains largely unknown. The hypothesis is that COPD induces specific sleep and breathing disturbances that remain a substantial source of morbidity in this disorder.
Current therapy for treating nocturnal disturbances in sleep and breathing in COPD including nocturnal oxygen has failed to improve morning fatigue and pulmonary function. This study promises to significantly alter our approach to the diagnosis and management of sleep disordered breathing in COPD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764165
|Contact: Erica Wolfe||410 550 email@example.com|
|Contact: Michelle Guzman||410 550 firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Bayview Medical Campus||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Erica Wolfe 410-550-2233 email@example.com|
|Principal Investigator:||Hartmut Schneider, M.D., Ph.D.||Johns Hopkins University|