- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05368662
Quality of Life and Quality of Sleep Studies in Children With Home Care Ventilation in the West of France (EQuaViSE)
May 5, 2022 updated by: University Hospital, Angers
Quality of Life and Quality of Sleep Studies in Children With Home Care Ventilation in Two Regions of France Pays de Loire and Bretagne
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: OLLIVIER Morgane, MD
- Phone Number: +33 2 41 35 38 29
- Email: MoOllivier@chu-angers.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Children with home ventilation
|
Evaluation of quality of life and quality of sleep by questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2022
Primary Completion (Anticipated)
June 24, 2025
Study Completion (Anticipated)
September 24, 2025
Study Registration Dates
First Submitted
May 5, 2022
First Submitted That Met QC Criteria
May 5, 2022
First Posted (Actual)
May 10, 2022
Study Record Updates
Last Update Posted (Actual)
May 10, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 49RC20_0239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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