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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: Oxygen; Other: High flow of room air

• Registration Number: NCT01764165
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2010-07-16
• Study Start: 2012-08
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxygen	Oxygen	nocturnal oxygen of 2 L/min
High Flow of room air	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States