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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
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
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Withdrawn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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
No
Learn more about this trial
Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients
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