Narcolepsy in ChildrenCOSACMNCT04561427
Pediatric Cohort Study
An observational study of Narcolepsy in Children, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Narcolepsy is a rare disease that affects 0.05% of the general population. It is characterized by a dysregulation of the sleep wake regulation that leads to uncontrolled sleep episode during day and a disorganized sleep during night. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Narcolepsy in Children
- What is being tested?
- Study of Sleep architecture in children with narcolepsy
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 1 Feb 2022
- Phase
- Observational
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children or adolescents (0 to 18 years old)
Who may be able to join
- Patients between 0 and 18 years old
- Patients diagnosed with primary or secondary narcolepsy
- From both gender
Who cannot join
- Patients diagnosed with another sleep disorder
- Healthy patients
- Patients older than 18 years old
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
: Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon
Lyon, 69500
Patricia Franco
About this study
Official title: Cohort Study on Sleep Architecture and Regulation, Cognitive Performance and Metabolism in Children With Narcolepsy
Narcolepsy is a rare disease that affects 0.05% of the general population. It is characterized by a dysregulation of the sleep wake regulation that leads to uncontrolled sleep episode during day and a disorganized sleep during night. These symptoms are due to a loss of hypocretin neurons in the brain leading to an inability to maintain wake properly. The physiopathology of this rare disease still needs investigations. Since we are a reference center for this disease, we propose to use patients files to better describe and document the sleep characteristics of these children, the cognitive performances, the effects of narcolepsy treatments on sleep architecture and the metabolic status of these children.
- Conditions
- Narcolepsy in Children
- Being tested
- Study of Sleep architecture in children with narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of Sleep architecture in children with narcolepsyOther
Evaluate the cognitive performances, the effects of narcolepsy treatments on sleep architecture and the metabolic status of these children
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Patients with narcolepsy | * Patients between 0 and 18 years old
* Patients diagnosed with primary or secondary narcolepsy
* From both gender Receives: Other: Study of Sleep architecture in children with narcolepsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep period (SP) evaluated by polysomnography (PSG)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
Total sleep time (TST) evaluated by polysomnography (PSG)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
Stage 1 duration evaluated by polysomnography (PSG)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
Stage 2 duration evaluated by polysomnography (PSG)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
Stage 3 duration evaluated by polysomnography (PSG)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
Stage 1 percentage evaluated by polysomnography (PSG)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
Stage 2 percentage evaluated by polysomnography (PSG)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
Stage 3 percentage evaluated by polysomnography (PSG)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
REM duration evaluated by polysomnography (PSG)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
REM percentage of TST evaluated by polysomnography (PSG)
In percentage of TST
Measured: During the 72 hours of the diagnostic' hospitalization
Sleep efficiency evaluated by polysomnography (PSG)
TST / SP in percentage
Measured: During the 72 hours of the diagnostic' hospitalization
Sleep latency evaluated by polysomnography (PSG)
In minutes, first epoch of NREM or REM sleep
Measured: During the 72 hours of the diagnostic' hospitalization
REM latency evaluated by polysomnography (PSG)
In minutes, first epoch of REM sleep from sleep onset
Measured: During the 72 hours of the diagnostic' hospitalization
Wake after sleep onset (WASO) duration evaluated by polysomnography (PSG)
In minutes between sleep onset and sleep offset,
Measured: During the 72 hours of the diagnostic' hospitalization
Micro-arousal index evaluated by polysomnography (PSG)
Number of event / hour
Measured: During the 72 hours of the diagnostic' hospitalization
Arousal index evaluated by polysomnography (PSG)
Measured: During the 72 hours of the diagnostic' hospitalization
Leg movements index evaluated by polysomnography (PSG)
Number of event / hour
Measured: During the 72 hours of the diagnostic' hospitalization
Apnea-hypopnea index evaluated by polysomnography (PSG)
Number of respiratory events / hour
Measured: During the 72 hours of the diagnostic' hospitalization
Mean saturation during sleep evaluated by polysomnography (PSG)
In percentage
Measured: During the 72 hours of the diagnostic' hospitalization
Minimal saturation during sleep evaluated by polysomnography (PSG)
In percentage
Measured: During the 72 hours of the diagnostic' hospitalization
Duration of SaO2<90% evaluated by polysomnography (PSG)
In percentage of total sleep time
Measured: During the 72 hours of the diagnostic' hospitalization
Index of desaturation > 3% evaluated by polysomnography (PSG)
Number of event / hour
Measured: During the 72 hours of the diagnostic' hospitalization
Maximal CO2 during non-REM sleep evaluated by polysomnography (PSG)
In mmHg
Measured: During the 72 hours of the diagnostic' hospitalization
Maximal CO2 during REM sleep evaluated by polysomnography (PSG)
In mmHg
Measured: During the 72 hours of the diagnostic' hospitalization
Sleep time with PCO2 > 50 mmHg / TST evaluated by polysomnography (PSG)
In percentage
Measured: During the 72 hours of the diagnostic' hospitalization
Sleep latency evaluated during multiple sleep latency test (MSLT)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
Stage 1 latency evaluated during multiple sleep latency test (MSLT)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
REM latency evaluated during multiple sleep latency test (MSLT)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
SOREM evaluated during multiple sleep latency test (MSLT)
In minutes
Measured: During the 72 hours of the diagnostic' hospitalization
Power in frequency bands delta, alpha, gamma, theta evaluated during PSG
Measured: During the 72 hours of the diagnostic' hospitalization
Mean Bedtime evaluated by actimetry
during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Wake up time evaluated by actimetry
during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Time in bed evaluated by actimetry
during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Total Sleep time evaluated by actimetry
during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Waking time evaluated by actimetry
during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Sleep period evaluated by actimetry
during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Sleep efficiency evaluated by actimetry
In percentage, during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean wake after sleep onset duration evaluated by actimetry
during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Sleep latency evaluated by actimetry
during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean fragmentation index evaluated by actimetry
In percentage, during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Immobile time evaluated by actimetry
In minutes, during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Moving time evaluated by actimetry
In minutes, during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Number of immobile phases evaluated by actimetry
during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Mean Number of one minute immobility periods evaluated by actimetry
during week-end days and week days
Measured: During 15 days before the diagnostic' hospitalization
Intellectual Quotient evaluated by the WISC
by a neuropsychologist.
Measured: During the 72 hours of the diagnostic' hospitalization
Attention evaluated by the BLAST
during neuropsychological evaluation
Measured: During the 72 hours of the diagnostic' hospitalization
Insomnia severity evaluated by Insomnia Severity Index (ISI)
Measured: During the 72 hours of the diagnostic' hospitalization
Depressive feelings evaluated by the Children Depression Inventory (CDI)
Measured: During the 72 hours of the diagnostic' hospitalization
Attention disorders symptoms evaluated by the Conners rating scale
Measured: During the 72 hours of the diagnostic' hospitalization
Fatigue evaluated by the Fatigue scale
Measured: During the 72 hours of the diagnostic' hospitalization
Estimated severity of the disease evaluated by the Severity scale
Measured: During the 72 hours of the diagnostic' hospitalization
Sleepiness evaluated by the Epworth sleepiness scale for children
Measured: During the 72 hours of the diagnostic' hospitalization
Sleepiness evaluated by the Karolinska scale
Measured: During the 72 hours of the diagnostic' hospitalization
Histamine rate in the cerebro-spinal fluid (CSF) , evaluated by lumbar punction
In pg/mL
Measured: During the 72 hours of the diagnostic' hospitalization
Circadian typology evaluated by the Horne and Ostberg questionnaire
Measured: During the 72 hours of the diagnostic' hospitalization
Body fat evaluated by DEXA
In percentage
Measured: During the 72 hours of the diagnostic' hospitalization
Lean mass evaluated by DEXA
In percentage
Measured: During the 72 hours of the diagnostic' hospitalization
Leptin evaluated by blood test
In ng/ml
Measured: During the 72 hours of the diagnostic' hospitalization
Total ghrelin evaluated by blood test
Measured: During the 72 hours of the diagnostic' hospitalization
Acylated ghrelin evaluated by blood test
In pg/mL
Measured: During the 72 hours of the diagnostic' hospitalization
Non-acylated ghrelin ghrelin evaluated by blood test
In pg/mL
Measured: During the 72 hours of the diagnostic' hospitalization
Fastin blood sugar evaluated by blood test
In mmol/L
Measured: During the 72 hours of the diagnostic' hospitalization
Fasting insulin evaluated by blood test
In mUI/L,
Measured: During the 72 hours of the diagnostic' hospitalization
Hba1C evaluated by blood test
In percentage
Measured: During the 72 hours of the diagnostic' hospitalization
TSH evaluated by blood test
In mUI/L
Measured: During the 72 hours of the diagnostic' hospitalization
T3 evaluated by blood test
In pmol/L
Measured: During the 72 hours of the diagnostic' hospitalization
T4 evaluated by blood test
In pmol/L
Measured: During the 72 hours of the diagnostic' hospitalization
Total cholesterol by blood test
In mmol/L
Measured: During the 72 hours of the diagnostic' hospitalization
LDL by blood test
In mmol/L
Measured: During the 72 hours of the diagnostic' hospitalization
HDL by blood test
In mmol/L
Measured: During the 72 hours of the diagnostic' hospitalization
Triglycerides by blood test
In mmol/L
Measured: During the 72 hours of the diagnostic' hospitalization
NFS by blood test
Measured: During the 72 hours of the diagnostic' hospitalization
Ionogram by blood test
Measured: During the 72 hours of the diagnostic' hospitalization
Epstein Barr Virus antibodies by serology
Positivity
Measured: During the 72 hours of the diagnostic' hospitalization
Hepatitis B antibodies by serology
Positivity
Measured: During the 72 hours of the diagnostic' hospitalization
Streptococcus antibodies by serology
Positivity
Measured: During the 72 hours of the diagnostic' hospitalization
HLA evaluated by genotyping
Presence of the known HLA factor of predisposition for narcolepsy,
Measured: During the 72 hours of the diagnostic' hospitalization
Urinary prolactin evaluated by urine test
Measured: During the 72 hours of the diagnostic' hospitalization
Urinary sulfatoxy-melatonin evaluated by urine test
Measured: During the 72 hours of the diagnostic' hospitalization
Urinary cortisol evaluated by urine test
Measured: During the 72 hours of the diagnostic' hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Feb 2019
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcolepsy in ChildrenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
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
- NCT04561427
- Sponsor's protocol ID
- COSACM_2020
- Acronym
- COSACM
- Status last verified
- Aug 2020
- First submitted
- 27 Aug 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on Sleep Architecture and Regulation, Cognitive Performance and Metabolism in Children With Narcolepsy
- ClinicalTrials.gov ID
- NCT04561427
- Acronym / sponsor ID
- COSACM / COSACM_2020
- Conditions
- Narcolepsy in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 23 Sep 2020 (actual)
- 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.
Narcolepsy is a rare disease that affects 0.05% of the general population. It is characterized by a dysregulation of the sleep wake regulation that leads to uncontrolled sleep episode during day and a disorganized sleep during night. These symptoms are due to a loss of hypocretin neurons in the brain leading to an inability to maintain wake properly. The physiopathology of this rare disease still needs investigations. Since we are a reference center for this disease, we propose to use patients files to better describe and document the sleep characteristics of these children, the cognitive performances, the effects of narcolepsy treatments on sleep architecture and the metabolic status of these children.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Patients with narcolepsy | – | Other: Study of Sleep architecture in children with narcolepsy* Patients between 0 and 18 years old * Patients diagnosed with primary or secondary narcolepsy * From both gender |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children or adolescents (0 to 18 years old)
Key inclusion criteria (3 listed)
- Patients between 0 and 18 years old
- Patients diagnosed with primary or secondary narcolepsy
- From both gender
Key exclusion criteria (3 listed)
- Patients diagnosed with another sleep disorder
- Healthy patients
- Patients older than 18 years old
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 |
|---|---|---|
| Study of Sleep architecture in children with narcolepsyEvaluate the cognitive performances, the effects of narcolepsy treatments on sleep architecture and the metabolic status of these children | Other | Pediatric Patients with narcolepsy |
Primary outcome
Sleep period (SP) evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
Total sleep time (TST) evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 1 duration evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 2 duration evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 3 duration evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 1 percentage evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 2 percentage evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 3 percentage evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
REM duration evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
REM percentage of TST evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In percentage of TST
Sleep efficiency evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
TST / SP in percentage
Sleep latency evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes, first epoch of NREM or REM sleep
REM latency evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes, first epoch of REM sleep from sleep onset
Wake after sleep onset (WASO) duration evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes between sleep onset and sleep offset,
Micro-arousal index evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
Number of event / hour
Arousal index evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
Leg movements index evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
Number of event / hour
Apnea-hypopnea index evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
Number of respiratory events / hour
Mean saturation during sleep evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In percentage
Minimal saturation during sleep evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In percentage
Duration of SaO2<90% evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In percentage of total sleep time
Index of desaturation > 3% evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
Number of event / hour
Maximal CO2 during non-REM sleep evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In mmHg
Maximal CO2 during REM sleep evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In mmHg
Sleep time with PCO2 > 50 mmHg / TST evaluated by polysomnography (PSG)
Time frame: During the 72 hours of the diagnostic' hospitalization
In percentage
Sleep latency evaluated during multiple sleep latency test (MSLT)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
Stage 1 latency evaluated during multiple sleep latency test (MSLT)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
REM latency evaluated during multiple sleep latency test (MSLT)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
SOREM evaluated during multiple sleep latency test (MSLT)
Time frame: During the 72 hours of the diagnostic' hospitalization
In minutes
Power in frequency bands delta, alpha, gamma, theta evaluated during PSG
Time frame: During the 72 hours of the diagnostic' hospitalization
Mean Bedtime evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Wake up time evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Time in bed evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Total Sleep time evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Waking time evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Sleep period evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Sleep efficiency evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
In percentage, during week-end days and week days
Mean wake after sleep onset duration evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Sleep latency evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean fragmentation index evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
In percentage, during week-end days and week days
Mean Immobile time evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
In minutes, during week-end days and week days
Mean Moving time evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
In minutes, during week-end days and week days
Mean Number of immobile phases evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Mean Number of one minute immobility periods evaluated by actimetry
Time frame: During 15 days before the diagnostic' hospitalization
during week-end days and week days
Intellectual Quotient evaluated by the WISC
Time frame: During the 72 hours of the diagnostic' hospitalization
by a neuropsychologist.
Attention evaluated by the BLAST
Time frame: During the 72 hours of the diagnostic' hospitalization
during neuropsychological evaluation
Insomnia severity evaluated by Insomnia Severity Index (ISI)
Time frame: During the 72 hours of the diagnostic' hospitalization
Depressive feelings evaluated by the Children Depression Inventory (CDI)
Time frame: During the 72 hours of the diagnostic' hospitalization
Attention disorders symptoms evaluated by the Conners rating scale
Time frame: During the 72 hours of the diagnostic' hospitalization
Fatigue evaluated by the Fatigue scale
Time frame: During the 72 hours of the diagnostic' hospitalization
Estimated severity of the disease evaluated by the Severity scale
Time frame: During the 72 hours of the diagnostic' hospitalization
Sleepiness evaluated by the Epworth sleepiness scale for children
Time frame: During the 72 hours of the diagnostic' hospitalization
Sleepiness evaluated by the Karolinska scale
Time frame: During the 72 hours of the diagnostic' hospitalization
Histamine rate in the cerebro-spinal fluid (CSF) , evaluated by lumbar punction
Time frame: During the 72 hours of the diagnostic' hospitalization
In pg/mL
Circadian typology evaluated by the Horne and Ostberg questionnaire
Time frame: During the 72 hours of the diagnostic' hospitalization
Body fat evaluated by DEXA
Time frame: During the 72 hours of the diagnostic' hospitalization
In percentage
Lean mass evaluated by DEXA
Time frame: During the 72 hours of the diagnostic' hospitalization
In percentage
Leptin evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In ng/ml
Total ghrelin evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
Acylated ghrelin evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In pg/mL
Non-acylated ghrelin ghrelin evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In pg/mL
Fastin blood sugar evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In mmol/L
Fasting insulin evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In mUI/L,
Hba1C evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In percentage
TSH evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In mUI/L
T3 evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In pmol/L
T4 evaluated by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In pmol/L
Total cholesterol by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In mmol/L
LDL by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In mmol/L
HDL by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In mmol/L
Triglycerides by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
In mmol/L
NFS by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
Ionogram by blood test
Time frame: During the 72 hours of the diagnostic' hospitalization
Epstein Barr Virus antibodies by serology
Time frame: During the 72 hours of the diagnostic' hospitalization
Positivity
Hepatitis B antibodies by serology
Time frame: During the 72 hours of the diagnostic' hospitalization
Positivity
Streptococcus antibodies by serology
Time frame: During the 72 hours of the diagnostic' hospitalization
Positivity
HLA evaluated by genotyping
Time frame: During the 72 hours of the diagnostic' hospitalization
Presence of the known HLA factor of predisposition for narcolepsy,
Urinary prolactin evaluated by urine test
Time frame: During the 72 hours of the diagnostic' hospitalization
Urinary sulfatoxy-melatonin evaluated by urine test
Time frame: During the 72 hours of the diagnostic' hospitalization
Urinary cortisol evaluated by urine test
Time frame: During the 72 hours of the diagnostic' hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy in Children, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Franco (4.27.85.60.52 ext. +33, patricia.franco@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep period (SP) evaluated by polysomnography (PSG) (time frame: During the 72 hours of the diagnostic' hospitalization). The study lists 80 primary outcomes in all. 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 23 Sep 2020.