Clinical trial NCT04660994: Contribution of an Educational Game for Continuous Positive Pressure/non-invasive Ventilation Therapeutic Education in Children
Official title: Contribution of an Educational Game for Continuous Positive Pressure/non-invasive Ventilation Therapeutic Education in Children
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep Disordered Breathing
Keywords: Nocturnal continuous positive airway pressure therapy
Nocturnal non-invasive ventilation therapy
Sleep disordered breathing
Therapeutic education
Educational game
Therapeutic compliance
Motivation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parents'feelings
timeFrame: Scale change from day 0 to day 30
Secondary outcomes:
measure: Feeling of children
timeFrame: Scale change from day 0 to day 30
measure: Parents' concerns or difficulties
timeFrame: Scale change from day 0 to day 30
measure: Family impact
timeFrame: Change from day 0 to day 30
measure: Functioning of the child
timeFrame: Change from day 0 to day 30
measure: Therapeutic compliance in hours
timeFrame: Change from day 8 to day 30
measure: Therapeutic compliance in days
timeFrame: Change from day 8 to day 30
measure: Motivation of parents
timeFrame: Change from day 0 to day 30
measure: Motivation of children
timeFrame: Change from day 0 to day 30
measure: Parents competence
timeFrame: Change from day 0 to day 30
measure: Children competence
timeFrame: Change from day 0 to day 30
measure: Effect of the TEP session on healthcare professionals
timeFrame: Change from day 0 to day 30
measure: Number of calls from parents
timeFrame: Day 30
measure: Score on Yapouni questionnaire for parents
timeFrame: Change from day 8 to day 30
measure: Score on Yapouni questionnaire for children
timeFrame: Change from day 8 to day 30
measure: Score on Yapouni questionnaire for healthcare professionals
timeFrame: Change from day 8 to day 30
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Brigitte Fauroux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: