Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years
NCT ID: NCT06455592
Last Updated: 2025-12-05
Study Results
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-11-17
2027-11-30
Brief Summary
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Evaluate the effect of adapted physical activity on the sleep of children with cancer from 5 to 16
Hypothesis :
Practice daily adapted physical activity improve the sleep of the 5 to 16 children with cancer
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Detailed Description
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This is a randomized, cross-over, open-label, two-armed parallel, unique center therapeutic trial comparing the effect of practice adapted physical activity only once during four days (conventional strategy) versus practice adapted physical activity each day during four days (experimental strategy) on the sleep of the children with blood cancer from 5 to 16 at the hospital in Clermont-Ferrand and at home.
The study will last four weeks with a wash-out week after 2 weeks. The outcomes are described later. The nurse informs and obtains the consent of the child and his parents. After statistical analysis of these two arms, it will be possible to determine the value of practice daily adapted physical activity on the sleep of children with blood cancer from 5 to 16 at the hospital and at home.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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standard
practice only once adapted physical activity in hospital and at home during four days
control arm
practice once adapted physical activity during 4 days
daily adapted physical activity
practice adapted physical activity daily in hospital and at home during four days
practice adapted physical activity
practice daily adapted physical activity during 4 days
Interventions
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practice adapted physical activity
practice daily adapted physical activity during 4 days
control arm
practice once adapted physical activity during 4 days
Eligibility Criteria
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Inclusion Criteria
* Subjects and their parents who were informed about the study and gave informed consent.
* Enrollment in the Social Security system
Exclusion Criteria
* Children under anxiolytic treatment
* Children with sleep disorders (sleep apnea)
* Children taking melatonin or sleeping pills
* Contraindication to adapted physical activity
* Refusal to participate on the part of the participant or his/her parents
* Holders of parental authority under curatorship, guardianship, safeguard of justice
* Pregnant or breast-feeding teenagers
5 Years
16 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Emmanuelle LABRAISE
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Lise Laclautre
Role: primary
Other Identifiers
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2023-A02575-40
Identifier Type: OTHER
Identifier Source: secondary_id
AOI 2022 LABRAISE
Identifier Type: -
Identifier Source: org_study_id
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