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

NCT04660994 | Withdrawn

• 2 other identifiers: APHP2009592020-A01737-32
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Feeling of children

  Scale change from day 0 to day 30

• Parents' concerns or difficulties

  Scale change from day 0 to day 30

• Family impact

  Change from day 0 to day 30

• Functioning of the child

  Change from day 0 to day 30

• Therapeutic compliance in hours

  Change from day 8 to day 30

Study Arms (2)

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

Interventions

Educational game OTHER

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.

Also known as: YAPOUNI

Therapeutic education and Yapouni educational game

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Non-communicating child.
• Child with major cognitive impairment.
• Child / parents not speaking French.
• Child in an unstable clinical condition.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Patient Compliance

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Brigitte Fauroux, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 9, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 25, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)