Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years

Sleep Clinical Trial

— APANYX  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455592
• Other study ID #: AOI 2022 LABRAISE
• Secondary ID: 2023-A02575-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adapted Physical Activity
• Blood Cancer
• Child, Only
• Hematologic Neoplasms
• Sleep

Intervention

Behavioral:
• practice adapted physical activity
practice daily adapted physical activity during 4 days

Other:
• control arm
practice once adapted physical activity during 4 days

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	children quality of life	parent-completed questionnaire	the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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