Pathogenesis and Outcomes of Sleep Disordered Breathing in Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT01764165|
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : October 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|COPD||Other: Oxygen Other: High flow of room air||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
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
- The evening to morning differences in expiratory airflow obstruction (FEV1/FVC) [ Time Frame: 4 years ]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 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764165
|United States, Maryland|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Hartmut Schneider, M.D., Ph.D.||Johns Hopkins University|