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

COPD Clinical Trial

Official title:

Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764165
• Other study ID #: R01HL105546-01
• Secondary ID: NA_00040333
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: October 4, 2016
• Start date: August 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep efficiency	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.	4 years	No
Other	Episodes of dynamic hyperinflation	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.	4 years	No
Primary	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.	4 years	No
Secondary	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.	4 Years	No
Secondary	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.	One Year	No