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

NCT05368662 | Recruiting

• 1 other identifier: 49RC20_0239
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Non Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Children with home ventilation

EXPERIMENTAL

Other: Quality of life and sleep questionnaire

Interventions

Quality of life and sleep questionnaire OTHER

Evaluation of quality of life and quality of sleep by questionnaires

Children with home ventilation

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU

Angers, Maine et Loire, 49933, France

RECRUITING

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

OLLIVIER Morgane, MD

CONTACT

2 41 35 38 29; MoOllivier@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: November 11, 2022
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)