COPD
Conditions
Keywords
COPD, Sleep, Supplemental oxygen, Breathing mechanics, nasal insufflation
Brief summary
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
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.
Interventions
OTHEROxygen
oxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep.
OTHERHigh flow of room air
Warm and humidified air at rates of 20 L/min will be delivered through a small nasal cannula throughout sleep
Sponsors
National Institutes of Health (NIH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The evening to morning differences in expiratory airflow obstruction (FEV1/FVC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percent rate of inspiratory flow limitation. | 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). | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency | 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 | 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. |
Countries
United States
Outcome results
None listed