Pathogenesis and Outcomes of Sleep Disordered Breathing in Chronic Obstructive Pulmonary Disease (COPD)
Completed · Not applicable
Conditions studied: COPD
In brief
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.
Key facts
- Study ID
- NCT01764165
- Run by
- Johns Hopkins University
- People needed
- 52
- Starts
- 2012-08-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2016-10-05
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Consenting adults over the age of 21
- BMI < 40 kg/m2
You may not qualify if…
- 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.
Where it is running
- Johns Hopkins — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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