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Lo studio clinico NCT06455592 (APANYX) per Figlio unico, Cancro del sangue, Attività fisica adattata, Sonno è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years (APANYX)
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La sperimentazione clinica NCT06455592 (APANYX) è uno studio interventistico per Figlio unico, Cancro del sangue, Attività fisica adattata, Sonno, attualmente in arruolamento. Avviato il 17 novembre 2025, prevede di arruolare 30 partecipanti. Sotto la guida di University Hospital, Clermont-Ferrand, dovrebbe concludersi entro il 1 novembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 5 dicembre 2025.
Sommario breve
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
Descrizione dettagliata
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.
Titolo ufficiale
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.
Condizioni
Figlio unicoCancro del sangueAttività fisica adattataSonnoAltri ID dello studio
- APANYX
- AOI 2022 LABRAISE
- 2023-A02575-40 (Altro identificativo) (2023-A02575-40)
Numero NCT
Data di inizio (effettiva)
2025-11-17
Ultimo aggiornamento pubblicato
2025-12-05
Data di completamento (stimata)
2027-11
Arruolamento (previsto)
30
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
child
blood cancer
adapted physical activity
sleep
hospital and home
blood cancer
adapted physical activity
sleep
hospital and home
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
Cross-over
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivostandard practice only once adapted physical activity in hospital and at home during four days | Braccio di controllo practice once adapted physical activity during 4 days |
Sperimentaledaily 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 |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Criteri di eleggibilità
Età idonea
Bambino
Età minima
5 Years
Sessi idonei
Tutti
- 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-FerrandContatti principali dello studio
Contatto: Lise Laclautre, 334.73.754.963, [email protected]
1 Centri dello studio in 1 paesi
CHU de Clermont-Ferrand, Clermont-Ferrand, France
Lise Laclautre, Contatto
Emmanuelle LABRAISE, Investigatore principale
In arruolamento