Metabolism Characteristics in the Children With Narcolepsy (NCT02799849) | Clinical Trial Compass
CompletedNot Applicable
Metabolism Characteristics in the Children With Narcolepsy
France24 participantsStarted 2013-12-20
Plain-language summary
A significant weight gain and obesity are observed for most patients with narcolepsy, mainly at the beginning of the disease and narcolepsy in young children. There is no specific study on the population and the consequences of overweight in the lives of these long-term patients. Narcoleptic patients gain weight significantly at the onset of their illness. It is also known that weight gain is not related to the treatment of narcolepsy. The etiology of obesity in narcoleptic patients is not established. Several assumptions were made (physical activity, leptin diet, metabolism). The reason and the pathophysiology of overweight and obesity in this population therefore remain unclear.
In this study, potential change in the total metabolism (24h) for narcoleptic children that could explain their tendency to obesity will be assessed ?
Who can participate
Age range
6 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
NARCOLEPTIC PATIENTS
* Girl or boy age\> 6 years \<18 years;
* Narcoleptic: defined by the ICSD diagnostic criteria 2 (International Classification of Sleep Disorders)
* Beginning of the troubles there more than 6 months
* Parental consent and agreement of the child.
HYPERSOMNIC PATIENTS
* Girl or boy age\> 6 years \<18 years;
* Hypersomnic : defined by the ICSD diagnostic criteria 2 (International Classification of Sleep Disorders)
* Beginning of the troubles there more than 6 months
* Parental consent and agreement of the child.
Exclusion Criteria:
NARCOLEPTIC PATIENTS
* Secondary Narcolepsy;
* Narcolepsy already treated with psychostimulant or anticataplectic;
* Restless legs;
* Sleep apnea syndrome;
* Obesity known outside narcolepsy cause;
* Absence of parental consent.
HYPERSOMNIC PATIENTS
* symptomatic or secondary hypersomnia;
* Hypersomnia already treated psychostimulant or anticataplectic; Restless legs;
* Sleep apnea syndrome;
* Pathology neurological, psychiatric, endocrine or concurrent;
* Lack of parental consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.