Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT04660994
Status:
WITHDRAWN
Last Update Posted:
2025-09-25
First Post:
2020-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of an Educational Game for Continuous Positive Pressure/Non-invasive Ventilation Therapeutic Education in Children
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Contribution of an Educational Game for Continuous Positive Pressure/Non-invasive Ventilation Therapeutic Education in Children
Status:
WITHDRAWN
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Abandoned project
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YAPOUNI
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-A01737-32 | OTHER | ID RCB number | View |