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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02884830
Other study ID # AK/16-05-73/4668AD
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date December 31, 2019

Study information

Verified date January 2020
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
continuous positive airway pressure
positive airway pressure given by a medical device through a nasal mask

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Outcome

Type Measure Description Time frame Safety issue
Primary sleep quality sleep efficiency, total sleep time, sleep architecture measured by polysomnography day 1
Secondary static hyperinflation measure of static hyperinflation by lung function test after the night spent with CPAP day 1
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