Sleep Disordered BreathingYAPOUNINCT04660994
Contribution of an Educational Game for Continuous Positive Pressure/Non-invasive Ventilation Therapeutic Education in Children
An observational study of Sleep Disordered Breathing, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Sleep Disordered Breathing
- What is being tested?
- Educational game
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Non-communicating child.
- Child with major cognitive impairment.
- Child / parents not speaking French.
- Child in an unstable clinical condition.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Sleep Disordered Breathing
- Being tested
- Educational game
- Keywords
- Nocturnal continuous positive airway pressure therapy, Nocturnal non-invasive ventilation therapy, Sleep disordered breathing, Therapeutic education, Educational game, Therapeutic compliance, Motivation
- Medical subject headings
- Sleep Apnea Syndromes, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational gameOther
Also called YAPOUNI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Scale change from day 0 to day 30
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from day 0 to day 30
Therapeutic compliance in hours
Average number of hours of CPAP / NIV use per night.
Measured: Change from day 8 to day 30
Therapeutic compliance in days
Average number of days of CPAP / NIV use.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from day 0 to day 30
Number of calls from parents
Number of calls from parents regarding to CPAP / NIV and Yapouni game.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from day 8 to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: Abandoned project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Brigitte Fauroux, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660994
- Sponsor's protocol ID
- APHP200959
- Other IDs
- 2020-A01737-32
- Acronym
- YAPOUNI
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2020
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of an Educational Game for Continuous Positive Pressure/Non-invasive Ventilation Therapeutic Education in Children
- ClinicalTrials.gov ID
- NCT04660994
- Acronym / sponsor ID
- YAPOUNI / APHP200959
- 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
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Abandoned project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Educational gameChildren with disordered breathing requiring CPAP or NIV and followed-up by the pediatric non-invasive ventilation and sleep unit of Necker-Enfants Malades hospital. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Non-communicating child.
- Child with major cognitive impairment.
- Child / parents not speaking French.
- Child in an unstable clinical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational gameAlso: YAPOUNIThe 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 | Therapeutic education and Yapouni educational game |
Primary outcome
Parents'feelings
Time frame: Scale change from day 0 to day 30
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.
15 secondary outcomes
Feeling of children
Time frame: Scale change from day 0 to day 30
Parents' concerns or difficulties
Time frame: Scale change from day 0 to day 30
Family impact
Time frame: Change from day 0 to day 30
Functioning of the child
Time frame: Change from day 0 to day 30
Therapeutic compliance in hours
Time frame: Change from day 8 to day 30
Therapeutic compliance in days
Time frame: Change from day 8 to day 30
Motivation of parents
Time frame: Change from day 0 to day 30
Motivation of children
Time frame: Change from day 0 to day 30
Parents competence
Time frame: Change from day 0 to day 30
Children competence
Time frame: Change from day 0 to day 30
Effect of the TEP session on healthcare professionals
Time frame: Change from day 0 to day 30
Number of calls from parents
Time frame: Day 30
Score on Yapouni questionnaire for parents
Time frame: Change from day 8 to day 30
Score on Yapouni questionnaire for children
Time frame: Change from day 8 to day 30
Score on Yapouni questionnaire for healthcare professionals
Time frame: Change from day 8 to day 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Fauroux, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disordered Breathing, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents'feelings (time frame: Scale change from day 0 to day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.