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NCT Number: NCT06455592

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

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

Recruiting

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location status: Recruiting

Location contact

Emmanuelle LABRAISE

PRINCIPAL_INVESTIGATOR

Lise Laclautre

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

practice adapted physical activity

Behavioral

practice daily adapted physical activity during 4 days

Control Arm

Other

practice once adapted physical activity during 4 days

Primary outcomes

  1. Quality of sleep

    Time frame: 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

    daily calendar with information about child's sleep complete by parents

Secondary outcomes

  1. Number of sleep's hour and night awakenings

    Time frame: 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

    wear a sleep recorder during the night

  2. rate of daily human physical activity in met/day

    Time frame: 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

    wear a wearable device allday and night long

  3. children quality of life

    Time frame: the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days

    parent-completed questionnaire

  4. chair stand-up test

    Time frame: 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

    maximum sit-up and stand-up from a chair during one minute

  5. vigilance status description

    Time frame: 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

    parent-completed questionnaire

  6. children's pain self evaluation

    Time frame: 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

    self evaluation of children's pain with the visial analog scale in vertical position quote from 0 to 10, 10=worst score

  7. fatigue status

    Time frame: 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

    parent-completed questionnaire

  8. inflammation markers

    Time frame: the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days

    C reactive protein and IL6 from daily blood test

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study 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.

Acronym: APANYX

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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