Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04660994
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Withdrawn
Phase
Start date December 2020
Completion date January 2022

See also
  Status Clinical Trial Phase
Completed NCT03927547 - Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders N/A
Completed NCT03105297 - To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep. Phase 2
Completed NCT02894242 - The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) N/A
Completed NCT02086448 - Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP) N/A
Completed NCT02188498 - Electrocardiography Data Analysis in Sleep Disorders
Completed NCT01120548 - Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients N/A
Completed NCT01004471 - An Exploratory Study of a Nasal Dilator Strip Phase 2
Completed NCT02851628 - The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort N/A
Completed NCT03748264 - User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application N/A
Active, not recruiting NCT02191085 - Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing N/A
Completed NCT01467856 - Sleep Disordered Breathing N/A
Completed NCT00909259 - Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing Phase 1
Terminated NCT03353064 - Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure N/A
Completed NCT03752580 - An Investigation to Test a Prototype Nasal Mask in the Home Setting N/A
Completed NCT02987985 - Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy Phase 3
Suspended NCT03964376 - Nasal High Flow Therapy in Surgical Patients With Unrecognized Obstructive Sleep Apnea N/A
Completed NCT03725839 - The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA) N/A
Completed NCT02938208 - An Investigation to Test a Prototype Full-face Mask in the Home Setting N/A
Completed NCT04086407 - Apnea Hypopnea Index Severity Versus Head Position During Sleep N/A
Terminated NCT02296840 - Post-operative Pain Control After Pediatric Adenotonsillectomy Phase 4