Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: continuous positive airway pressure

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sham CPAP; 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; positive airway pressure given by a medical device through a nasal mask
Active Comparator: Efficace CPAP; 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; positive airway pressure given by a medical device through a nasal mask

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: AK/16-05-73/4668AD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No