Child, OnlyAPANYXNCT06455592
Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years
A study testing practice adapted physical activity in people with Child, Only and Blood Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Child, Only, Blood Cancer, Adapted Physical Activity
- What is being tested?
- practice adapted physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre
Emmanuelle LABRAISE
About this study
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.
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
Read the detailed 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.
- Conditions
- Child, Only, Blood Cancer, Adapted Physical Activity, Sleep
- Being tested
- practice adapted physical activity, control arm
- Keywords
- child, blood cancer, adapted physical activity, sleep, hospital and home
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
practice adapted physical activityBehavioural
practice daily adapted physical activity during 4 days
control armOther
practice once adapted physical activity during 4 days
| Study group | Role | What they receive |
|---|---|---|
| standard | Active comparator | practice only once adapted physical activity in hospital and at home during four days Receives: Other: control arm |
| daily adapted physical activity | Experimental | practice adapted physical activity daily in hospital and at home during four days Receives: Behavioral: practice adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of sleep
daily calendar with information about child's sleep complete by parents
Measured: 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 outcomes (8)
Number of sleep's hour and night awakenings
wear a sleep recorder during the night
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start17 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- experimental, randomized, cross-over, single-center therapeutic trial, controlled
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle LABRAISE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455592
- Sponsor's protocol ID
- AOI 2022 LABRAISE
- Other IDs
- 2023-A02575-40
- Acronym
- APANYX
- Status last verified
- Dec 2025
- First submitted
- 31 May 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06455592
- Acronym / sponsor ID
- APANYX / AOI 2022 LABRAISE
- Conditions
- Child, Only, Blood Cancer, Adapted Physical Activity, Sleep
- Keywords
- child, blood cancer, adapted physical activity, sleep, hospital and home
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental, randomized, cross-over, single-center therapeutic trial, controlled
| Arm | Type | Receives |
|---|---|---|
| standard | Active comparator | Other: control armpractice only once adapted physical activity in hospital and at home during four days |
| daily adapted physical activity | Experimental | Behavioral: practice adapted physical activitypractice adapted physical activity daily in hospital and at home during four days |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| practice adapted physical activitypractice daily adapted physical activity during 4 days | Behavioural | daily adapted physical activity |
| control armpractice once adapted physical activity during 4 days | Other | standard |
Primary outcome
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
8 secondary outcomes
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
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
children quality of life
Time frame: the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuelle LABRAISE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing practice adapted physical activity in people with Child, Only and Blood Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.