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Metabolism Characteristics in the Children With Narcolepsy

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Civil Hospices of Lyon

Status

Unknown

Conditions

Narcolepsy

Treatments

Other: Sleep and metabolism assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT02799849
2012-759

Details and patient eligibility

About

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 ?

Enrollment

60 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Narcoleptic patients
Other group
Treatment:
Other: Sleep and metabolism assessment
hypersomnic patients
Other group
Treatment:
Other: Sleep and metabolism assessment

Trial contacts and locations

1

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Central trial contact

Sonia GALLETTI; Patricia FRANCO, MD

Data sourced from clinicaltrials.gov

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