Baltimore, Maryland 21224

  • COPD

Purpose:

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 summary:

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.


Criteria:

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.


NCT ID:

NCT01764165


Primary Contact:

Principal Investigator
Hartmut Schneider, M.D., Ph.D.
Johns Hopkins University


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 22, 2021

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