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Completed

NCT Number: NCT01764165

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

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen

Other

oxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep.

Other names: supplemental oxygen, nocturnal oxygen

High flow of room air

Other

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

Primary outcomes

  1. The evening to morning differences in expiratory airflow obstruction (FEV1/FVC)

    Time frame: 4 years

    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 outcomes

  1. The percent rate of inspiratory flow limitation.

    Time frame: 4 Years

    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.

  2. Effect of High flow nasal insufflation of air on exercise capacity (6 minute walk test).

    Time frame: One Year

    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 outcomes

  1. Sleep efficiency

    Time frame: 4 years

    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.

  2. Episodes of dynamic hyperinflation

    Time frame: 4 years

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2013
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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