Clinical trial NCT01764165: Pathogenesis and Outcomes of Sleep Disordered Breathing in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
Sleep
Supplemental oxygen
Breathing mechanics
nasal insufflation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-01-09
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The evening to morning differences in expiratory airflow obstruction (FEV1/FVC)
timeFrame: 4 years
Secondary outcomes:
measure: The percent rate of inspiratory flow limitation.
timeFrame: 4 Years
measure: Effect of High flow nasal insufflation of air on exercise capacity (6 minute walk test).
timeFrame: One Year
Other outcomes:
measure: Sleep efficiency
timeFrame: 4 years
measure: Episodes of dynamic hyperinflation
timeFrame: 4 years
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hartmut Schneider, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider H, Krishnan V, Pichard LE, Patil SP, Smith PL, Schwartz AR. Inspiratory duty cycle responses to flow limitation predict nocturnal hypoventilation. Eur Respir J. 2009 May;33(5):1068-76. doi: 10.1183/09031936.00063008. Epub 2009 Jan 7.