Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients

NCT ID: NCT02884830

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2019-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

continuous positive airway pressure

Intervention Type: DEVICE

positive airway pressure given by a medical device through a nasal mask

Efficace CPAP

Continuous positive airway pressure is a CPAP given at effective pressure to decrease the work of breathing in COPD patients

Group Type: ACTIVE_COMPARATOR

continuous positive airway pressure

Intervention Type: DEVICE

positive airway pressure given by a medical device through a nasal mask

Interventions

continuous positive airway pressure

positive airway pressure given by a medical device through a nasal mask

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AK/16-05-73/4668AD

Identifier Type: -

Identifier Source: org_study_id