Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients

Study Overview
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Brief Summary
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Static hyperinflation is frequent in Chronic obstructive pulmonary disease (COPD) , resulting in increased end expiratory lung volume and positive end expiratory pressure (PEEPi) at the end of a normal expiration. Static hyperinflation worsens the work of breathing is increases patient's dyspnea. The application of a continuous positive airway pressure (CPAP) has been shown to improve static hyperinflation and to decrease the work of breathing. Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation. The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and functional respiratory parameters.

Detailed Description
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Chronic obstructive pulmonary disease (COPD) is characterized by an airflow obstruction, inducing a flow limitation. As a consequence, we observe in these patients an increased end expiratory lung volume and a positive end expiratory pressure (PEEPi) at the end of a normal expiration. Patients are breathing at higher pulmonary volumes: this is the concept of static hyperinflation. This worsens the breathing pattern because in this situation, the work of breathing is increased such that dyspnea increases. The application of a continuous positive airway pressure (CPAP) has been shown to improve static hyperinflation and to decrease the work of breathing. Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation, cough, depression. Moreover, normal physiological changes occuring during sleep in COPD patients are leading to deterioration of gaseous exchanges. The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and functional respiratory parameters.

Official Title
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Does Nocturnal Continuous Positive Airway Pressure Use Improves Sleep Quality in Chronic Obstructive Pulmonary Disease Patients?

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: continuous positive airway pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable chronic obstructive pulmonary disease patients exhibiting a FEV1<80 %, Exclusion Criteria: Known sleep apnea syndrome or other sleep disease interfering with sleep quality Body mass index > 30 kg/m2 heart failure hypnotics intake

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham CPAP<br>Sham continuous positive airway pressure is a CPAP given at too low pressure to have any physiological effect on upper airways patency and on lung volumes | Device: continuous positive airway pressure<br>* positive airway pressure given by a medical device through a nasal mask<br>|
| Active Comparator: Efficace CPAP<br>Continuous positive airway pressure is a CPAP given at effective pressure to decrease the work of breathing in COPD patients | Device: continuous positive airway pressure<br>* positive airway pressure given by a medical device through a nasal mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep quality | sleep efficiency, total sleep time, sleep architecture measured by polysomnography | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| static hyperinflation | measure of static hyperinflation by lung function test after the night spent with CPAP | day 1 |