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

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: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Effect of CPAP on respiratory work and cardiac function indices during wakefulness; Device: CPAP

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; st period: Spontaneous breathing for 10 minutes; nd period: CPAP for 10 minutes; 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; st period: Spontaneous breathing for 10 minutes; nd period: CPAP for 10 minutes; 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; st period: Spontaneous breathing for 10 minutes; nd period: CPAP for 10 minutes; 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

Outcome Measure	Time Frame
oesophageal pressure during spontaneous breathing and during continuous positive airway pressure	up to 5 days
trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure	up to 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure	up to 5 days
Polysomnography during spontaneous breathing	up to 5 days
sleep questionnaire	up to 5 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Philips Healthcare; Unité de Recherche Clinique Necker Cochin, France

Publications and helpful links

General Publications

• Amaddeo A, Khraiche D, Khirani S, Meot M, Jais JP, Bonnet D, Fauroux B. Continuous positive airway pressure improves work of breathing in pediatric chronic heart failure. Sleep Med. 2021 Jul;83:99-105. doi: 10.1016/j.sleep.2021.04.003. Epub 2021 Apr 19.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2015
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): July 30, 2017

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimated): April 10, 2015

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: polysomnography; sleep; Heart failure; CPAP; child; work of breathing; cardiac function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2014 A1907-40