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New treatment option for Sleep Duration
Official title Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep)
ClinicalTrials.gov ID: NCT06341179
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Any genetic, neurological, endocrinological or psychiatric condition that affects growth, metabolism, eating behaviors, cognitive function, or body...
- 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...
- 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...
See the full eligibility 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.
- Any genetic, neurological, endocrinological or psychiatric condition that affects growth, metabolism, eating behaviors, cognitive function, or body weight (for example: dwarfism, epilepsy, attention deficit...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Hvidovre, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Hvidovre, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.