NCT05368662 Quality of Life and Quality of Sleep Studies in Children with Home Care Ventilation in the West of France
| NCT ID | NCT05368662 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Quality of Life |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-11-11 |
| Primary Completion | 2026-06-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2022-11-11 with a primary completion date of 2026-06-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05368662 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 17 Years, studying Quality of Life. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05368662 currently recruiting?
Yes, NCT05368662 is actively recruiting participants. Contact the research team at MoOllivier@chu-angers.fr for enrollment information.
Where is the NCT05368662 trial being conducted?
This trial is being conducted at Angers, France.
Who is sponsoring the NCT05368662 clinical trial?
NCT05368662 is sponsored by University Hospital, Angers. The trial plans to enroll 160 participants.