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Contribution of an Educational Game for Continuous Positive Pressure/Non-invasive Ventilation Therapeutic Education in Children (YAPOUNI)

A

Assistance Publique - Hôpitaux de Paris

Status

Withdrawn

Conditions

Sleep Disordered Breathing

Treatments

Other: Educational game

Study type

Observational

Funder types

Other

Identifiers

NCT04660994
APHP200959
2020-A01737-32 (Other Identifier)

Details and patient eligibility

About

A growing number of children with obstructive sleep apnea syndrome (OSAS) or nocturnal alveolar hypoventilation syndrome are treated with continuous positive airway pressure (CPAP) or nocturnal non-invasive ventilation (NIV) therapy.

The compliance of the child and his caregivers with CPAP / NIV therapy may be challenging.

The use of an educational game (Yapouni) aims at improving communication around CPAP / NIV between the child and his caregivers, and may facilitate the compliance with CPAP / NIV at home, by increasing the motivation for using CPAP / NIV at home.

The aim of the study is to assess the parents' feelings regarding the use of CPAP / NIV on day 0 (D0) and one month (D30) later in a standard group: therapeutic education (TEP) versus a group: TEP + Yapouni.

Full description

The study concerns children with severe obstructive sleep apnea syndrome and / or alveolar hypoventilation requiring the initiation of CPAP/NIV. Most of these children have associated diseases (craniofacial malformations, trisomy 21, Prader Willi syndrome or neuromuscular diseases) which are accompanied by an abnormality of nocturnal breathing causing abnormalities in gas exchange and abnormalities of architecture and quality of sleep, with deleterious consequences on neurocognitive, cardiovascular and metabolic functions. In the absence of other treatments, the initiation of CPAP or NIV during sleep can correct the respiratory anomalies and the deleterious consequences. Optimal compliance with treatment is therefore essential for its efficacy and therapeutic education (TEP) plays a key role.

The compliance of the child and his caregivers with CPAP / NIV therapy may be challenging.

The use of an educational game (Yapouni) aims at improving communication around CPAP / NIV between the child and his caregivers, and may facilitate the compliance with CPAP / NIV at home, by increasing the motivation for using CPAP / NIV at home.

The Yapouni educational game is based on a hot air balloon that will fly according to the number of hours the child has slept with his/her CPAP / NIV. Thus, the longer the child sleeps with his/her CPAP / NIV, the farther and higher his/her hot air balloon will fly in the sky. The game includes wild cards and rewards that are worked out with the child and his/her parents for an optimal individualized adaptation.

The aim of the study is to assess the parents' feelings regarding the use of CPAP / NIV on D0 and D30 later in a standard group: therapeutic education (TEP) versus a group: TEP + Yapouni.

Sex

All

Ages

3 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children aged 3 to 16 years old with severe obstructive sleep apnea syndrome and / or alveolar hypoventilation requiring the initiation of a treatment with CPAP / NIV in the pediatric non-invasive ventilation and sleep unit of Necker-Enfants Malades hospital.
  • Child's caregivers not opposing to the patient's participation in research.

Exclusion criteria

  • Non-communicating child.
  • Child with major cognitive impairment.
  • Child / parents not speaking French.
  • Child in an unstable clinical condition.

Trial design

0 participants in 2 patient groups

Therapeutic education
Description:
Children with disordered breathing requiring CPAP or NIV and followed-up by the pediatric non-invasive ventilation and sleep unit of Necker-Enfants Malades hospital.
Therapeutic education and Yapouni educational game
Description:
Children with disordered breathing requiring CPAP or NIV and followed-up by the pediatric non-invasive ventilation and sleep unit of Necker-Enfants Malades hospital.
Treatment:
Other: Educational game

Trial contacts and locations

1

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Central trial contact

Brigitte Fauroux, MD, PhD; Hélène Morel

Data sourced from clinicaltrials.gov

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