Quality of Life and Quality of Sleep Studies in Children With Home Care Ventilation in the West of France
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quality of life and sleep questionnaire.
- Who it may be relevant to
- Registry conditions: Quality of Life, Non Invasive Ventilation. Basic parameters: 6 months — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Quality of life and sleep questionnaire
Evaluation of quality of life and quality of sleep by questionnaires
Primary outcome measures
- Quality of life in children with home care ventilation [Time frame: 30 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU — Angers
Identifiers
NCT: NCT05368662 · 49RC20_0239