Skip to main content
OpenTrials
Completed

NCT Number: NCT02414126

Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

8 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Effect of CPAP on respiratory work and cardiac function indices during wakefulness

Other

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

CPAP

Device

Primary outcomes

  1. oesophageal pressure during spontaneous breathing and during continuous positive airway pressure

    Time frame: up to 5 days

  2. trans-diaphragmatic pressure during spontaneous breathing and during continuous positive airway pressure

    Time frame: up to 5 days

Secondary outcomes

  1. Ultrasound cardiac function indices during spontaneous breathing and during continuous positive airway pressure

    Time frame: up to 5 days

  2. Polysomnography during spontaneous breathing

    Time frame: up to 5 days

  3. sleep questionnaire

    Time frame: up to 5 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Philips Healthcare
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: IC-E-PPC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2015
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.