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

Quality of Life Clinical Trial

— EQuaViSE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05368662
• Other study ID #: 49RC20_0239
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 24, 2025

Study information

• Verified date: May 2022
• Source: University Hospital, Angers
• Contact: OLLIVIER Morgane, MD
• Phone: 2 41 35 38 29
• Email: MoOllivier[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: September 24, 2025
• Est. primary completion date: June 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Non Invasive Ventilation
• Quality of Life

Intervention

Other:
• Quality of life and sleep questionnaire
Evaluation of quality of life and quality of sleep by questionnaires

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life in children with home care ventilation	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	30 months