Quality of Life and Quality of Sleep Studies in Children with Home Care Ventilation in the West of France

Not Applicable

Recruiting

• Conditions: Quality of Life; Non Invasive Ventilation
• Interventions: Other: Quality of life and sleep questionnaire

• Registration Number: NCT05368662
• Lead Sponsor: University Hospital, Angers

Brief Summary

Home ventilation in children, invasive or non invasiv,e is an interesting treatment for different disease which cause chronic respiratory impairement. The aim of this treatment is to support alveolar hypoventilation. Concerned diseases are : neuro-muscular disease, upper airways pathologies, whest wall or lung pathologies, central control ventilation disease. Prevalence of home children ventilation is in augmentation in France. The last national study in 2021 about infants show a prevalence of 9.3/100 000. Advantages with home children ventilation in addition of improvement of survey, it can observe improvement of quality of life and improvement of the quality of their sleep. Quality of life is a thematic less studying. Last studies show an impairment of quality of life in all thematics compare to children with no disease but also with infants whith chronic diseases. This study were about few numbers of patients. The aim of this study is to evaluate the quality of life and the quality of sleep in children with home ventilation to complete the actual littérature to improve the respiratory care of this population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-10
• Study Start: 2022-11-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-06-24
• Study Completion: 2026-09-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Child aged 6 months to 17 years treated with non-invasive ventilation at home for at least 1 month
• Follow-up in one of the five centers participating in the study (Angers, Nantes, Le Mans, Rennes and Brest)
• Informed consent form signed by both parents, or holder of parental authority, for the participation of their child
• To be affiliated or beneficiary of social security

Exclusion Criteria

• Parents with poor command of the French language, implying not being able to complete the various questionnaires
• Refusal of the child to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with home ventilation	Quality of life and sleep questionnaire	-

Primary Outcome Measures

Name	Time	Method
Quality of life in children with home care ventilation	30 months	The quality of life of this population is assessed using the generic PedsQL 4.0 score. The questions are classified according to different categories regardless of age: physical capacity, emotional functioning, social relationships and schooling, or for children under 2 years old, relationship life and cognitive functioning. The evaluation relates to the past month. The questionnaire presents different questions depending on the age group

Trial Locations

Locations (1)

CHU; 🇫🇷 Angers, Maine et Loire, France