Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients

Not Applicable

Withdrawn

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: continuous positive airway pressure

• Registration Number: NCT02884830
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-31
• Study Start: 2019-01-07
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efficace CPAP	continuous positive airway pressure	Continuous positive airway pressure is a CPAP given at effective pressure to decrease the work of breathing in COPD patients
Sham CPAP	continuous positive airway pressure	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

Primary Outcome Measures

Name	Time	Method
sleep quality	day 1	sleep efficiency, total sleep time, sleep architecture measured by polysomnography

Secondary Outcome Measures

Name	Time	Method
static hyperinflation	day 1	measure of static hyperinflation by lung function test after the night spent with CPAP