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Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients

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ClinicalTrials.gov Identifier: NCT02884830
Recruitment Status : Not yet recruiting
First Posted : August 31, 2016
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: continuous positive airway pressure Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Nocturnal Continuous Positive Airway Pressure Use Improves Sleep Quality in Chronic Obstructive Pulmonary Disease Patients?
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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




Primary Outcome Measures :
  1. sleep quality [ Time Frame: day 1 ]
    sleep efficiency, total sleep time, sleep architecture measured by polysomnography


Secondary Outcome Measures :
  1. static hyperinflation [ Time Frame: day 1 ]
    measure of static hyperinflation by lung function test after the night spent with CPAP



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884830


Contacts
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Contact: Marie Bruyneel, MD PhD +3225354219 marie_bruyneel@stpierre-bru.be
Contact: Audrey CHirumberro +3225353211 audrey_chirumberro@stpierre-bru.be

Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre

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Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT02884830     History of Changes
Other Study ID Numbers: AK/16-05-73/4668AD
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases