Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients

NCT02884830 | Withdrawn

• 1 other identifier: AK/16-05-73/4668AD
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• sleep quality

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

  day 1

Secondary Outcomes (1)

• static hyperinflation

  day 1

Study Arms (2)

Sham CPAP

PLACEBO COMPARATOR

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

Efficace CPAP

ACTIVE COMPARATOR

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

Interventions

continuous positive airway pressure DEVICE

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

Efficace CPAP; Sham CPAP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable chronic obstructive pulmonary disease patients exhibiting a FEV1\<80 %,

You may not qualify if:

• Known sleep apnea syndrome or other sleep disease interfering with sleep quality
• Body mass index \> 30 kg/m2
• heart failure
• hypnotics intake

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: August 31, 2016
• Study Start: January 7, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share