NarcolepsyNarcolepsyNCT02799849
Metabolism Characteristics in the Children With Narcolepsy
A study testing Sleep and metabolism assessment in people with Narcolepsy, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Narcolepsy
- What is being tested?
- Sleep and metabolism assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2013to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- NARCOLEPTIC PATIENTS
- Secondary Narcolepsy;
- Narcolepsy already treated with psychostimulant or anticataplectic;
- Restless legs;
- Sleep apnea syndrome;
- Obesity known outside narcolepsy cause;
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- 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 locations and contacts
1 site in 1 country.
France1 site
Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère Enfant
Bron, 69677
About this study
Official title: Is There a Change in the Total Metabolism Over 24 Hours for Narcoleptic Children That Could Explain Their Tendency to Obesity?
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
- Being tested
- Sleep and metabolism assessment
- Keywords
- narcolepsy, metabolism
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep and metabolism assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Narcoleptic patients | Other | Not described Receives: Other: Sleep and metabolism assessment |
| hypersomnic patients | Other | Not described Receives: Other: Sleep and metabolism assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 15 days
Secondary outcomes (22)
Determination of the metabolism at hospital
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 hospital over 24 hours.
Measured: 18 days
Basal energy expenditure
The basal metabolism (MET) measured by accelerometer (Actical, BodyMedia SW Actiheart) will be compared to the values of energy expenditure (kcal) measured by indirect calorimetry fasting.
Measured: 18 days
Energy expenditure and diet-induced thermogenesis
Energy expenditure (kcal) measured by indirect calorimetry after lunch (with counting calories ingested).
Measured: 18 days
Sympathetic activity
Estimated from IBI (Interbeat Interval) measured by Actiheart.
Measured: 18 days
Food intake
Caloric intake evaluation (kcal per day) during hospitalization (food intake recording) and at home during three days ( two days during the week and one day during the week-end) evaluated by questionnary.
Measured: 18 days
Fasting peptide YY
Measured: 18 days
Body weight
bodyweight (kg)
Measured: 18 days
Body height
Body height (cm)
Measured: 18 days
Waist and hips circumference
Waist and hips circumference (cm)
Measured: 18 days
Measurement of neck
Measurement of neck (cm)
Measured: 18 days
Anthropometric measurements
Measurement of BMI Z-score
Measured: 18 days
Appetite
appetite evaluation by visual analog scale before each meal
Measured: 18 days
Hunger
hunger evaluation by visual analog scale before each meal
Measured: 18 days
Fasting IL6-8 levels
Measured: 18 days
Fasting adiponectin
Measured: 18 days
Fasting resistin
Measured: 18 days
Fasting MCP1
Measured: 18 days
Fasting PostPrandial
Measured: 18 days
Fasting GLP1 (glucagon-like peptide-1)
Measured: 18 days
Fasting Hba1C
Measured: 18 days
Body mass index z score
Measured: 18 days
sleep duration
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start20 Dec 2013
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799849
- Sponsor's protocol ID
- 2012-759
- Acronym
- Narcolepsy
- Status last verified
- Dec 2025
- First submitted
- 3 May 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Change in the Total Metabolism Over 24 Hours for Narcoleptic Children That Could Explain Their Tendency to Obesity?
- ClinicalTrials.gov ID
- NCT02799849
- Acronym / sponsor ID
- Narcolepsy / 2012-759
- Conditions
- Narcolepsy
- Keywords
- narcolepsy, metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Dec 2013 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ?
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narcoleptic patients | Other | Other: Sleep and metabolism assessment |
| hypersomnic patients | Other | Other: Sleep and metabolism assessment |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- NARCOLEPTIC PATIENTS
- Secondary Narcolepsy;
- Narcolepsy already treated with psychostimulant or anticataplectic;
- Restless legs;
- Sleep apnea syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep and metabolism assessment | Other | Narcoleptic patients, hypersomnic patients |
Primary outcome
Determination of the metabolism at home
Time frame: 15 days
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).
22 secondary outcomes
Determination of the metabolism at hospital
Time frame: 18 days
Basal energy expenditure
Time frame: 18 days
Energy expenditure and diet-induced thermogenesis
Time frame: 18 days
Sympathetic activity
Time frame: 18 days
Food intake
Time frame: 18 days
Fasting peptide YY
Time frame: 18 days
Body weight
Time frame: 18 days
Body height
Time frame: 18 days
Waist and hips circumference
Time frame: 18 days
Measurement of neck
Time frame: 18 days
Anthropometric measurements
Time frame: 18 days
Appetite
Time frame: 18 days
Hunger
Time frame: 18 days
Fasting IL6-8 levels
Time frame: 18 days
Fasting adiponectin
Time frame: 18 days
Fasting resistin
Time frame: 18 days
Fasting MCP1
Time frame: 18 days
Fasting PostPrandial
Time frame: 18 days
Fasting GLP1 (glucagon-like peptide-1)
Time frame: 18 days
Fasting Hba1C
Time frame: 18 days
Body mass index z score
Time frame: 18 days
sleep duration
Time frame: 18 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep and metabolism assessment in people with Narcolepsy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the metabolism at home (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.