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

NCT ID: NCT05368662

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2026-09-24

Brief Summary

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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.

Detailed Description

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Conditions

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Quality of Life Non Invasive Ventilation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Children with home ventilation

Group Type EXPERIMENTAL

Quality of life and sleep questionnaire

Intervention Type OTHER

Evaluation of quality of life and quality of sleep by questionnaires

Interventions

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Quality of life and sleep questionnaire

Evaluation of quality of life and quality of sleep by questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU

Angers, Maine et Loire, France

Site Status RECRUITING

Countries

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France

Central Contacts

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OLLIVIER Morgane, MD

Role: CONTACT

2 41 35 38 29 ext. +33

Facility Contacts

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Morgane Ollivier, MD

Role: primary

33 00241355088

Anne-Catherine Aube-Nathier, PhD

Role: backup

0033241355496

Other Identifiers

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49RC20_0239

Identifier Type: -

Identifier Source: org_study_id

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