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

This study is currently recruiting participants.
Verified January 2013 by Johns Hopkins University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Hartmut Schneider, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01764165
First received: July 16, 2010
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  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.


Condition Intervention
COPD
 Other: Oxygen
Other: High flow of room air

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The evening to morning differences in expiratory airflow obstruction (FEV1/FVC) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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:
  • The percent rate of inspiratory flow limitation. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
    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). [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Sleep efficiency [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    We hypothesize that delivering warm and humidified air at a rate of 20 L/min over the entire night improves sleep efficiency compared to oxygen treatment.

  • Episodes of dynamic hyperinflation [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The combination of in- and expiratory flow limitation can lead to dynamic hyperinflation during sleep. We hypothesize that compared to oxygen, high flow nasal insufflation of warm and humidified air at a rate of 20 L/min will reduce the number of breaths associated with dynamic hyperinflation.


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oxygen
nocturnal oxygen of 2 L/min
 Other: Oxygen
oxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep.
Other Names:
  • supplemental oxygen
  • nocturnal oxygen
Experimental: 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)
 Other: High flow of room air
Warm and humidified air at rates of 20 L/min will be delivered through a small nasal cannula throughout sleep
Other Names:
  • TNI: Transnasal insufflation
  • Open CPAP
  • Optiflow

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

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764165

Contacts
Contact: Erica Wolfe 410 550 2233 ewolfe4@jhmi.edu
Contact: Michelle Guzman 410 550 6336 mguzman4@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Campus Recruiting
Baltimore, Maryland, United States, 21224
Contact: Erica Wolfe     410-550-2233     ewolfe4@jhmi.edu    
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Hartmut Schneider, M.D., Ph.D. Johns Hopkins University
  More Information

Publications:

Responsible Party: Hartmut Schneider, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01764165     History of Changes
Other Study ID Numbers: R01HL105546-01, NA_00040333
Study First Received: July 16, 2010
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
COPD
Sleep
Supplemental oxygen
Breathing mechanics
nasal insufflation

Additional relevant MeSH terms:
Respiratory Aspiration
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Sleep Apnea Syndromes
Lung Diseases, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013