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

Sponsor
University Hospital, Angers (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05368662
Collaborator
(none)
160
Enrollment
1
Arm
39.8
Anticipated Duration (Months)

Study Details

Study Description

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, 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of life and sleep questionnaire
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 24, 2025
Anticipated Study Completion Date :
Sep 24, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Children with home ventilation

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

Outcome Measures

Primary Outcome Measures

  1. Quality of life in children with home care ventilation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT05368662
Other Study ID Numbers:
  • 49RC20_0239
First Posted:
May 10, 2022
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 10, 2022