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L'essai clinique NCT06455592 (APANYX) pour Enfant unique, Cancer du sang, Activité physique adaptée, Sommeil est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years (APANYX)
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L'étude clinique NCT06455592 (APANYX) est un essai interventionnel pour Enfant unique, Cancer du sang, Activité physique adaptée, Sommeil. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 septembre 2024, avec un objectif de 30 participants. Dirigé par University Hospital, Clermont-Ferrand, l'essai devrait être terminé d'ici le 1 septembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 12 juin 2024.
Résumé succinct
Main objective :
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
Description détaillée
Medical process are leading to an increase in the survival of children/adolescents undergoing treatment for blood cancer. Caregivers need to focus on optimizing these patients' quality of life during and after the disease. Sleep is essential to their development. Sleep disorders are symptoms reported by patients. They have a negative impact on their quality of life. Adapted physical activity sessions are offered in pediatric oncology departments, but sedentary behavior persists. The hypothesis is that the daily practice of adapted physical activity will improve sleep in patients treated for blood cancer.
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.
Titre officiel
Effect of Practicing Adapted Physical Activity (APA) on Sleep Quality in Children From 5 Years of Age and Adolescents up to 16 Years of Age Undergoing Treatment for a Hematologic Malignancy.
Conditions
Enfant uniqueCancer du sangActivité physique adaptéeSommeilAutres identifiants de l'essai
- APANYX
- AOI 2022 LABRAISE
- 2023-A02575-40 (Autre Identifiant) (2023-A02575-40)
Numéro NCT
Date de début (réel)
2024-09
Dernière mise à jour publiée
2024-06-12
Date de fin (estimée)
2026-09
Inscription (estimée)
30
Type d'essai
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
child
blood cancer
adapted physical activity
sleep
hospital and home
blood cancer
adapted physical activity
sleep
hospital and home
Objectif principal
Prévention
Plan d'attribution
Randomisé
Modèle d'intervention
Croisé
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifstandard practice only once adapted physical activity in hospital and at home during four days | Bras de contrôle practice once adapted physical activity during 4 days |
Expérimentaldaily 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 |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Quality of sleep | daily calendar with information about child's sleep complete by parents | the morning and the evening, from the morning of the first day to the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Number of sleep's hour and night awakenings | wear a sleep recorder during the night | Each night from the bedtime to the wake up time, from the bedtime of the first day to the wake up time of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days |
rate of daily human physical activity in met/day | wear a wearable device allday and night long | from the morning of the first day to the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days |
children quality of life | parent-completed questionnaire | the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days |
chair stand-up test | maximum sit-up and stand-up from a chair during one minute | the morning of the first day and the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days |
vigilance status description | parent-completed questionnaire | at 10am, 2pm and 6pm from the first day to the third day and only at 10am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days |
children's pain self evaluation | self evaluation of children's pain with the visial analog scale in vertical position quote from 0 to 10, 10=worst score | at 8am and 6pm from the first day to the third day and only at 8am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days |
fatigue status | parent-completed questionnaire | at 10am, 2pm and 6pm from the first day to the third day and only at 10am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days |
inflammation markers | C reactive protein and IL6 from daily blood test | the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days |
Critères d'éligibilité
Âges éligibles
Enfant
Âge minimum
5 Years
Sexes éligibles
Tous
- Children from 5 to 16 with haematological cancer undergoing treatment
- Subjects and their parents who were informed about the study and gave informed consent.
- Enrollment in the Social Security system
- Children on high-dose corticosteroids
- 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
University Hospital, Clermont-FerrandContact central de l'essai
Contact: Lise Laclautre, 334.73.754.963, [email protected]
1 Centres de l'essai dans 1 pays
CHU de Clermont-Ferrand, Clermont-Ferrand, France
Lise Laclautre, Contact
Emmanuelle LABRAISE, Investigateur principal