NCT06341179 Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep)
| NCT ID | NCT06341179 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Copenhagen |
| Condition | Sleep Duration |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2024-08-13 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 142 school-aged children (6-12 years) who have a BMI above average, defined as age- and sex-specific BMI Z-score above zero using WHO reference standards, and habitually sleep for ≤ 9 h/night. Data will be collected before and after a 3-month sleep extension intervention, and after a 6-month follow-up (at months 0, 3, and 9). The collection of data is mainly related to the main study. However, some optional examinations will be conducted on a first come, first serve basis, consisting of substudy-I (metabolic mechanisms, n=60) and substudy-II (learning mechanisms, n=142). The primary objective is to assess the effects of sleep extension by \~45 min/night, achieved by going to bed 60-90 min earlier, on adiposity and learning ability in school-aged children who have a BMI for age and sex above average, and sleep less than recommended for their age.
Eligibility Criteria
Inclusion Criteria: * Age: 6-12 years old (inclusive range). * Weight status: having a BMI above average, defined as an age- and sex-specific BMI Z-score above zero using reference standards from the WHO. * Sleep duration: sleeping ≤9 h/night on the basis of sleep diaries filled in by the children's parents, based on recommendations by the American Academy of Sleep Medicine and the Sleep Health Foundation. Exclusion Criteria: * Any genetic, neurological, endocrinological or psychiatric condition that affects growth, metabolism, eating behaviors, cognitive function, or body weight (for example: dwarfism, epilepsy, attention deficit hyperactivity disorder, head trauma, β-thalassemia, hypothyroid-ism, hyperthyroidism, type I diabetes). * Any sleep-related disorder (for example: obstructive sleep apnea, parasomnias, narcolepsy, restless leg syndrome). * Regular use of prescribed or over-the-counter medications that influence study outcomes. * Irregular school schedule. * If a child's parents live separately, the child is allowed to sleep at both households. How-ever, if one of the parents does not wish to carry out the sleep intervention and follow given instructions, then the child should only sleep at their household Friday, Saturday and/or Sunday night. * In the circumstance where the child does not speak or understand Danish, the child's parents do not have to speak or understand Danish, as long as both parties can speak and understand English. * Participation in other research studies. * Metal implants and claustrophobia (only for substudy-II).
Contact & Investigator
Faidon Magkos, PhD
PRINCIPAL INVESTIGATOR
University of Copenhagen, Department of Nutrition, Exercise and Sports
Frequently Asked Questions
Who can join the NCT06341179 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Sleep Duration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06341179 currently recruiting?
Yes, NCT06341179 is actively recruiting participants. Contact the research team at fma@nexs.ku.dk for enrollment information.
Where is the NCT06341179 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Copenhagen, Denmark, Hvidovre, Denmark.
Who is sponsoring the NCT06341179 clinical trial?
NCT06341179 is sponsored by University of Copenhagen. The principal investigator is Faidon Magkos, PhD at University of Copenhagen, Department of Nutrition, Exercise and Sports. The trial plans to enroll 142 participants.