Actively Recruiting

Phase Not Applicable
Age: 6Months - 17Years
All Genders
ID05368662

Quality of Life and Quality of Sleep Studies in Children with Home Care Ventilation in Two Regions of France Pays De Loire and Bretagne

Led by University Hospital, Angers · Updated on 2025-03-19

160

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The trial focuses on children aged 6 months to 17 years who require home ventilation, either invasive or non-invasive, due to chronic respiratory impairments caused by conditions such as neuromuscular disease, upper airway pathologies, chest wall or lung problems, and central control ventilation disorders. Home ventilation is increasingly used in France, with recent studies indicating a prevalence of 9.3 per 100,000 infants. This research aims to better understand how home ventilation affects the quality of life and sleep quality in these children, addressing gaps in existing literature that showed impairments compared to healthy children and those with other chronic diseases. Participants will undergo evaluation using questionnaires designed to assess their quality of life and sleep quality while receiving home ventilation. The study is conducted in five centers across France, including Angers, Nantes, Le Mans, Rennes, and Brest. The intervention consists of completing these questionnaires to gather data over the study period. Children involved in the study will be followed for 30 months, during which their quality of life related to home care ventilation will be monitored. Researchers will collect data through the questionnaires to measure outcomes. Participation involves regular follow-up at the designated centers, and informed consent is required from parents or legal guardians. The study aims to contribute valuable information to improve respiratory care and support for children using home ventilation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Months - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Quality of Life and Sleep Assessment

Duration - 30 months

Participants complete questionnaires to evaluate quality of life and quality of sleep while on home ventilation.

Periodic questionnaire assessments during the study period

Trial Site Locations

Total: 1 location

1

CHU

Angers, Maine et Loire, France, 49933

Actively Recruiting

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Research Team

O

OLLIVIER Morgane, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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