Metabolism Characteristics in the Children With Narcolepsy

NCT02799849 | Completed

• 1 other identifier: 2012-759
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 ?

Conditions

Narcolepsy

Keywords

narcolepsy; metabolism

Outcome Measures

Primary Outcomes (1)

• Determination of the metabolism at home

  Total energy expenditure in kilocalories per minute, including basal metabolic rate (MET) metabolism related to the activity (EEA), and physical activity (PA) measured by accelerometer (Actical) evaluated at home (15 days including scholar and non-scholar days).

  15 days

Secondary Outcomes (22)

• Determination of the metabolism at hospital

  18 days

• Basal energy expenditure

  18 days

• Energy expenditure and diet-induced thermogenesis

  18 days

• Sympathetic activity

  18 days

• Food intake

  18 days

Study Arms (2)

Narcoleptic patients

OTHER

Other: Sleep and metabolism assessment

hypersomnic patients

OTHER

Other: Sleep and metabolism assessment

Interventions

Sleep and metabolism assessment OTHER

Narcoleptic patients; hypersomnic patients

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère Enfant

Bron, 69677, France

Location

MeSH Terms

Conditions

Narcolepsy

Interventions

Sleep

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: June 15, 2016
• Study Start: December 20, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)