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

Primary Purpose

COPD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen
High flow of room air
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Sleep, Supplemental oxygen, Breathing mechanics, nasal insufflation

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

oxygen

High Flow of room air

Arm Description

nocturnal oxygen of 2 L/min

Warm and humidified air at a rate of 20 L/min through a small nasal cannula (similar to oxygen cannula)

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
July 16, 2010
Last Updated
October 4, 2016
Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01764165
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, Sleep, Supplemental oxygen, Breathing mechanics, nasal insufflation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxygen
Arm Type
Active Comparator
Arm Description
nocturnal oxygen of 2 L/min
Arm Title
High Flow of room air
Arm Type
Experimental
Arm Description
Warm and humidified air at a rate of 20 L/min through a small nasal cannula (similar to oxygen cannula)
Intervention Type
Other
Intervention Name(s)
Oxygen
Other Intervention Name(s)
supplemental oxygen, nocturnal oxygen
Intervention Description
oxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep.
Intervention Type
Other
Intervention Name(s)
High flow of room air
Other Intervention Name(s)
TNI: Transnasal insufflation, Open CPAP, Optiflow
Intervention Description
Warm and humidified air at rates of 20 L/min will be delivered through a small nasal cannula throughout sleep
Primary Outcome Measure Information:
Title
The evening to morning differences in expiratory airflow obstruction (FEV1/FVC)
Description
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
The percent rate of inspiratory flow limitation.
Description
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.
Time Frame
4 Years
Title
Effect of High flow nasal insufflation of air on exercise capacity (6 minute walk test).
Description
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.
Time Frame
One Year
Other Pre-specified Outcome Measures:
Title
Sleep efficiency
Description
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.
Time Frame
4 years
Title
Episodes of dynamic hyperinflation
Description
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.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartmut Schneider, M.D., Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19129290
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.
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Pathogenesis and Outcomes of Sleep Disordered Breathing in Chronic Obstructive Pulmonary Disease (COPD)

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