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NCT Number: NCT05368662

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

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.

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Key information

Conditions

Quality of Life Non Invasive Ventilation

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life and sleep questionnaire

Other

Evaluation of quality of life and quality of sleep by questionnaires

Primary outcomes

  1. Quality of life in children with home care ventilation

    Time frame: 30 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

OLLIVIER Morgane, MD

CONTACT

[email protected]

2 41 35 38 29 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study 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

Acronym: EQuaViSE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 10, 2022
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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