Pathogenesis and Outcomes of Sleep Disordered Breathing in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD

Conditions
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COPD

Intervention / Treatment
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* Other: Oxygen
* Other: High flow of room air


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting adults over the age of 21 BMI < 40 kg/m2 Exclusion Criteria: Diagnosed with sleep apnea (apnea and hypopneas of >10 events/hr). A sleep efficiency of <30%, or a prior diagnosis of disorders that impair sleep architecture. Unstable cardiovascular disease (decompensated heart failure, myocardial infarction within the past 3 months, revascularization procedure within the past 3 months, unstable arrhythmias, uncontrolled hypertension (BP > 190/110)). Severe renal insufficiency requiring dialysis. Liver cirrhosis. A recent acute illness in a 6 weeks period prior to the sleep studies. We will exclude subjects with severe daytime hypoxemia (Oxyhemoglobin saturation (SaO2) <80% or partial pressure of oxygen (PaO2) <55 mmHg at rest). Chronic use of sedatives or respiratory depressants that would affect sleep quality (e.g., benzodiazepines or other hypnotics or narcotics). Pregnancy. Tracheostomy or other significant oropharyngeal or nasopharyngeal surgery, in the last 6 months. Narcolepsy and other neurological disorders such as Parkinson's Disease. Severe hepatic insufficiency. Bleeding disorders or Coumadin use. Allergy to lidocaine or benzocaine. Language/dementia/psychiatric issues - the participant must be able to provide consent.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxygen<br>nocturnal oxygen of 2 L/min | Other: Oxygen<br>* oxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep.<br>* Other names: nocturnal oxygen;|
| Experimental: High Flow of room air<br>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<br>* Warm and humidified air at rates of 20 L/min will be delivered through a small nasal cannula throughout sleep<br>* Other names: Optiflow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evening to morning differences in expiratory airflow obstruction (FEV1/FVC) | 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. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent rate of inspiratory flow limitation. | 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. | 4 Years | 
| Effect of High flow nasal insufflation of air on exercise capacity (6 minute walk test). | 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. | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Sleep, Supplemental oxygen, Breathing mechanics, nasal insufflation