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

U

University Hospital, Angers

Status

Enrolling

Conditions

Non Invasive Ventilation
Quality of Life

Treatments

Other: Quality of life and sleep questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT05368662
49RC20_0239

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

6 months to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

160 participants in 1 patient group

Children with home ventilation
Experimental group
Treatment:
Other: Quality of life and sleep questionnaire

Trial contacts and locations

1

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Central trial contact

OLLIVIER Morgane, MD

Data sourced from clinicaltrials.gov

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