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



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 80
Updated:4/2/2016
Start Date:August 2012
End Date:December 2016
Contact:Erica Wolfe
Email:ewolfe4@jhmi.edu
Phone:410 550 2233

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Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD

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.

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.

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.
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