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

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.

Study Overview

• Status: Withdrawn
• Conditions: Sleep Disordered Breathing
• Intervention / Treatment: Other: Educational game

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Therapeutic education; 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; 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.	Other: Educational game; 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 game is explained at Necker Hospital during the therapy education for CPAP/NIV and used at home for 1 month.; Other Names: YAPOUNI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parents'feelings	Quantitative score at the parental feelings questionnaire about the CPAP/NIV initiation process. Home made questionnaire of 5 questions with responses by visual analogue scale from 0 to 100; 0 is the worst feeling and 100 the best.	Scale change from day 0 to day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeling of children	Quantitative score of the questionnaire of feelings of the children about the CPAP/NIV initiation process. Home made questionnaire of 5 questions with responses by visual analogue scale from 0 to 10; 0 is the worst feeling and 10 the best.	Scale change from day 0 to day 30
Parents' concerns or difficulties	Score on the parental concerns and difficulties questionnaire regarding the health of their children. Questionnaire of 6 questions of 7-level ordinal scale of answer; 0 is the worst feeling and 100 the best.	Scale change from day 0 to day 30
Family impact	Pediatric Quality of Life Inventory, Parent-Proxy Report (PEDSQL) questionnaire on family impact of the child's illness (s) rated from 0 to 100, high results being associated with a better quality of life.	Change from day 0 to day 30
Functioning of the child	Pediatric Quality of Life Inventory, Child-Self Report (PEDSQ) questionnaire on the child functioning rated from 0 to 100, high results being associated with a better quality of life.	Change from day 0 to day 30
Therapeutic compliance in hours	Average number of hours of CPAP / NIV use per night.	Change from day 8 to day 30
Therapeutic compliance in days	Average number of days of CPAP / NIV use.	Change from day 8 to day 30
Motivation of parents	Parent motivation scale (adaptation of the situational motivation scale). Questionnaire of 9 questions of 7-level ordinal scale of answer ; 0 is the worst feeling and 100 the best.	Change from day 0 to day 30
Motivation of children	Child motivation scale (adaptation of the situational motivation scale). Questionnaire of 3 questions with responses by visual analogue scale from 0 to 10; 0 is the worst score and 10 the highest motivation.	Change from day 0 to day 30
Parents competence	Parents competence scale (adaptation of the perceived competence scale). Questionnaire of 4 questions of 5-level ordinal scale of answer; 0 is the worst feeling and 100 the best.	Change from day 0 to day 30
Children competence	Children competence scale (adaptation of the perceived competence scale). Questionnaire of 2 questions with responses by visual analogue scale from 0 to 10; 0 is the worst score and 10 the highest competence feeling.	Change from day 0 to day 30
Effect of the TEP session on healthcare professionals	Score at the questionnaire on the effect of the session on healthcare professionals. Questionnaire of 5 questions of 7-level ordinal scale of answer, the higher the score, the more positive the feeling ; 0 is the worst feeling and 100 the best.	Change from day 0 to day 30
Number of calls from parents	Number of calls from parents regarding to CPAP / NIV and Yapouni game.	Day 30
Score on Yapouni questionnaire for parents	Parents' evaluation of the game. Questionnaire of 5 questions of 7-level ordinal scale of answer, the higher the score, the more positive the appreciation ; 0 is the worst feeling and 100 the best.	Change from day 8 to day 30
Score on Yapouni questionnaire for children	Evaluation of the game by children. Questionnaire of 3 questions with responses by visual analogue scale from 0 to 10; 0 is the worst score and 10 the highest appreciation.	Change from day 8 to day 30
Score on Yapouni questionnaire for healthcare professionals	Evaluation of the game by healthcare professionals. Questionnaire of 6 questions of 7-level ordinal scale of answer, the higher the score, the more positive the appreciation ; 0 is the worst feeling and 100 the best.	Change from day 8 to day 30

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Brigitte Fauroux, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Sleep disordered breathing; Motivation; Therapeutic compliance; Therapeutic education; Nocturnal continuous positive airway pressure therapy; Nocturnal non-invasive ventilation therapy; Educational game
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Sleep Apnea Syndromes; Patient Compliance
• Other Study ID Numbers: APHP200959; 2020-A01737-32 (Other Identifier: ID RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No