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NCT05368662 | Not yet recruiting | Quality of Life


Quality of Life and Quality of Sleep Studies in Children With Home Care Ventilation in the West of France
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, we 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 our 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.

Condition or disease

Quality of Life

Non Invasive Ventilation

Intervention/treatment

Quality of life and sleep questionnaire

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 160 participants
Masking : None (Open Label)
Primary Purpose : Other
Official Title : Quality of Life and Quality of Sleep Studies in Children With Home Care Ventilation in Two Regions of France Pays de Loire and Bretagne
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : June 24, 2025
Estimated Study Completion Date : September 24, 2025
Arm Intervention/treatment

Experimental: Children with home ventilation

Other: Quality of life and sleep questionnaire

Ages Eligible for Study: 6 Months to 17 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

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

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

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