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

NCT ID: NCT02414126

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-10
• Study Completion Date: 2017-07-30

Brief Summary

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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Children with dilated cardiomyopathy with an ejection fraction

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

CPAP

Intervention Type: DEVICE

Children with univentricular congenital heart disease

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

CPAP

Intervention Type: DEVICE

Children with left valvulopathy

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

CPAP

Intervention Type: DEVICE

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

CPAP

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 8 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 33991896 (View on PubMed)

Other Identifiers

2014 A1907-40

Identifier Type: -

Identifier Source: org_study_id