Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure (IC-E-PPC)

September 5, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Adult patients with heart failure (HF) have an increased work of breathing and are at increased risk for obstructive and/or central apnea during sleep. Noninvasive continuous positive airway pressure (CPAP) has proved its efficacy in decreasing the work of breathing and improving sleep-disordered breathing in these patients.

The aim of the study is to analyze the work of breathing and objective and subjective sleep quality in children with HF and to evaluate the ability of noninvasive CPAP to decrease the work of breathing and improve cardiac output during wakefulness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study starts with the measurement during wakefulness of

  • the breathing pattern and work of breathing
  • and cardiac function during 5 min after 10 min of stable and calm spontaneous breathing (SB) Then the same measurement are made during 5 min after 10 min of stable and calm breathing during non-invasive CPAP Then a third measurement is made of
  • the breathing pattern and work of breathing
  • and cardiac function during 5 min after 10 min a stable and calm SB

Polysomnography is then performed during the following night during SB in order to assess objective sleep quality.

Subjective sleep quality is assessed on the following morning in children > 6 years of age by validated sleep questionnaires.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 months to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A child with HF and having:
  • Dilated cardiomyopathy with an ejection fraction <45%
  • Univentricular congenital heart disease
  • Left ventricular valvulopathy
  • Age 8 months to 17 years
  • Signed informed consent by the owner (s) of parental authority and investigator
  • Patient affiliated to a social security scheme or entitled (excluding MEAs)
  • Comparison of results depending on the status T21 / T21 not.

Exclusion Criteria:

  • HF with use of inotropic drugs during the last 30 days.
  • Contra indication to CPAP or inability to maintain the airway or adequately remove phlegm, risk of aspiration of gastric contents, acute sinusitis or diagnosis of otitis media, epistaxis, hypotension.
  • Associated pathology may be responsible alone an obstructive apnea (ENT or maxillofacial malformation pathology, abnormalities of the upper airway, obesity with BMI z-score> 2), a central apnea syndrome (Chiari malformation), or alveolar hypoventilation (neuromuscular disease, cystic fibrosis or bronchopulmonary dysplasia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Children with dilated cardiomyopathy with an ejection fraction
Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness

Comparison of three periods of 3 hours

  1. st period: Spontaneous breathing for 10 minutes
  2. nd period: CPAP for 10 minutes
  3. rd period: Spontaneous breathing for 10 minutes to check the return to baseline.

After each period, the following parameters will be recorded during 5 minutes:

  • oesogastric pressures
  • air flow
  • gas exchange
  • right and left cardiac function

Patients > 6 years old will assess their dyspnea on a visual analogue scale

Device: CPAP
Active Comparator: Children with univentricular congenital heart disease
Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness

Comparison of three periods of 3 hours

  1. st period: Spontaneous breathing for 10 minutes
  2. nd period: CPAP for 10 minutes
  3. rd period: Spontaneous breathing for 10 minutes to check the return to baseline.

After each period, the following parameters will be recorded during 5 minutes:

  • oesogastric pressures
  • air flow
  • gas exchange
  • right and left cardiac function

Patients > 6 years old will assess their dyspnea on a visual analogue scale

Device: CPAP
Active Comparator: Children with left valvulopathy
Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness

Comparison of three periods of 3 hours

  1. st period: Spontaneous breathing for 10 minutes
  2. nd period: CPAP for 10 minutes
  3. rd period: Spontaneous breathing for 10 minutes to check the return to baseline.

After each period, the following parameters will be recorded during 5 minutes:

  • oesogastric pressures
  • air flow
  • gas exchange
  • right and left cardiac function

Patients > 6 years old will assess their dyspnea on a visual analogue scale

Device: CPAP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
oesophageal pressure during spontaneous breathing and during continuous positive airway pressure
Time Frame: up to 5 days
up to 5 days
trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure
Time Frame: up to 5 days
up to 5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure
Time Frame: up to 5 days
up to 5 days
Polysomnography during spontaneous breathing
Time Frame: up to 5 days
up to 5 days
sleep questionnaire
Time Frame: up to 5 days
up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Philips Healthcare
Unité de Recherche Clinique Necker Cochin, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014 A1907-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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