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Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

continuous positive airway pressure

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sham CPAP

Efficace CPAP

Arm Description

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

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

Outcomes

Primary Outcome Measures

sleep quality

sleep efficiency, total sleep time, sleep architecture measured by polysomnography

Secondary Outcome Measures

static hyperinflation

measure of static hyperinflation by lung function test after the night spent with CPAP

Full Information

NCT ID

NCT02884830

First Posted

August 26, 2016

Last Updated

January 27, 2020

Sponsor

Centre Hospitalier Universitaire Saint Pierre

1. Study Identification

Unique Protocol Identification Number

NCT02884830

Brief Title

Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Withdrawn

Why Stopped

the protocol is too complex and we are not able to recruit appropriate patients

Study Start Date

January 7, 2019 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sham CPAP

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Efficace CPAP

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

continuous positive airway pressure

Intervention Description

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

Primary Outcome Measure Information:

Title

sleep quality

Description

sleep efficiency, total sleep time, sleep architecture measured by polysomnography

Time Frame

day 1

Secondary Outcome Measure Information:

Title

static hyperinflation

Description

measure of static hyperinflation by lung function test after the night spent with CPAP

Time Frame

day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Plan to Share IPD

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Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients

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