An observational study in Narcolepsy Type 1, sponsored by I.M. Sechenov First Moscow State Medical University. Completed at 11 sites in Russian Federation. Open to participants aged 7 Years to 78 Years. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by I.M. Sechenov First Moscow State Medical University · Observational
The study is the first attempt in post-Soviet Russian history to collect and analyze the existing available data of narcolepsy cohort in order to get prove characteristics of narcolepsy in Russia according to known data. Investigators created the system of national narcolepsy centers in Russia - Russian narcolepsy network, with a purpose of collecting clinical and neurophysiological data with subsequent analyze and formation of Russian narcolepsy profile.
First reports of narcolepsy with cataplexy in Russia were made by Mankovsky in 1925 (narcolepsy with cataplexy, NC). The largest series of patients (n=110) was reported by A. Vein in 1964. Narcolepsy remains however until today relatively unknown in Russia. The aim of this study is to report clinical and polysomnographic (PSG)/multiple sleep latency test (MSLT) results in a Russian population and compare them with the European narcolepsy network (n=1099) reported (Luca G, Haba-Rubio J, Dauvilliers Y, Lammers GJ, Overeem S, Donjacour CE, Mayer G, Javidi S, Iranzo A, Santamaria J, Peraita-Adrados R, Hor H, Kutalik Z, Plazzi G, Poli F, Pizza F, Arnulf I, Lecendreux M, Bassetti C, Mathis J, Heinzer R, Jennum P, Knudsen S, Geisler P, Wierzbicka A, Feketeova E, Pfister C, Khatami R, Baumann C, Tafti M; European Narcolepsy Network. Clinical, polysomnographic and genome-wide association analyses of narcolepsy with cataplexy: a European Narcolepsy Network study. J Sleep Res. 2013 Oct;22(5):482-95. doi: 10.1111/jsr.12044. Epub 2013 Mar 18. PMID: 23496005., 2013).
For the purpose of this study only patients with narcolepsy with cataplexy were considered because of the uncertainty about the diagnosis of narcolepsy without cataplexy.
In order to create a network of sleep centers with expertise/interest in narcolepsy 79 centers from 27 Russian cities were connected in 2019. A total of 11 centers officially joined the Russian Narcolepsy Network (rnane.ru) and agreed to participate in the current study. A standardized questionnaire, similar to the one reported by the EU-NN in a series of 1099 patients (Luca G, Haba-Rubio J, Dauvilliers Y, Lammers GJ, Overeem S, Donjacour CE, Mayer G, Javidi S, Iranzo A, Santamaria J, Peraita-Adrados R, Hor H, Kutalik Z, Plazzi G, Poli F, Pizza F, Arnulf I, Lecendreux M, Bassetti C, Mathis J, Heinzer R, Jennum P, Knudsen S, Geisler P, Wierzbicka A, Feketeova E, Pfister C, Khatami R, Baumann C, Tafti M; European Narcolepsy Network. Clinical, polysomnographic and genome-wide association analyses of narcolepsy with cataplexy: a European Narcolepsy Network study. J Sleep Res. 2013 Oct;22(5):482-95. doi: 10.1111/jsr.12044. Epub 2013 Mar 18. PMID: 23496005., 2013) was sent by mail to the 11 centers. The questionnaire included the following parameters:
149 studies on the registry are indexed under Narcolepsy; 33 are open to participants now.
This study's enrollment of 89 is below the median of 120 across 34 observational studies indexed under Narcolepsy.
Browse Narcolepsy studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men and women aged 6-80 who have been diagnosed with narcolepsy type I, met inclusion criteria and who(or whose representatives in case of being under 18 years) agreed to participate in studying.
Exclusion Criteria:
Narcolepsy patients in Russia gathered according to criteria.
date of birth
year of birth
Time frame: during 1-3 years after beginning and when patient and data are available
gender
male or female
Time frame: during 1-3 years after beginning and when patient and data are available
height
meters
Time frame: during 1-3 years after beginning and when patient and data are available
weight
kilograms
Time frame: during 1-3 years after beginning and when patient and data are available
BMI at diagnosis
Weight and height will be combined to report BMI in kg/m\^2 at the time of diagnosis
Time frame: during 1-3 years after beginning and when patient and data are available
age at EDS (excessive daytime sleepioness) onset
Age when EDS first time was reported by patient
Time frame: during 1-3 years after beginning and when patient and data are available
age at cataplexy onset
Age when cataplexy first time was reported by patient
Time frame: during 1-3 years after beginning and when patient and data are available
frequency of cataplexy attacks at diagnosis
Reported at diagnosis. The frequency of cataplexy was assessed by a scale from 1 to 5, reporting rare to very frequent cataplexy attacks: 1 = one or less cataplexy attacks per year; 2 = more than one cataplexy attack per year but less than one per month; 3 = more than one attack per month but less than one per week; 4 = more than one per week but less than one per day; 5 = at least one cataplexy attack per day.
Time frame: during 1-3 years after beginning and when patient and data are available
ESS score at diagnosis
Unit of Measure at diagnosis
Time frame: during 1-3 years after beginning and when patient and data are available
Apnea-hypopnea index (AHI)
PSG at diagnosis, Unit of Measure at diagnosis
Time frame: during 1-3 years after beginning and when patient and data are available
Periodic leg movements during sleep index (PLMSI)
Number of episodes and hours of sleep combined to report PLMSI in episodes per hour.
Time frame: during 1-3 years after beginning and when patient and data are available
Sleep onset latency at diagnosis
Time from lights off to the first epoch scored as sleep in PSG. Measured in minutes.
Time frame: during 1-3 years after beginning and when patient and data are available
Sleep latency
Time from lights off to the first epoch scored as sleep in MSLT. Measured in minutes.
Time frame: during 1-3 years after beginning and when patient and data are available
Number of SOREM
It was defined as the occurrence of an epoch of REM sleep within 15 min after the first epoch scored as sleep. Then investigators calculated the percentage of SOREMPs of the total number of naps: percentage of naps with SOREMPs.
Time frame: during 1-3 years after beginning and when patient and data are available
Frequently of sleep paralysis, hypnagogic/hypnopompic hallucinations and poor nocturnal sleep, co-morbidities (sleep-related, somatic or psychiatric) and treatment when available.
Percentage of occurence in group.
Time frame: during 1-3 years after beginning and when patient and data are available
summarization of collected database with European one
analyzing and comparison collected data with European one leading to final summarization of studying
Time frame: 1 year after receiving data from sleep centers from Russia and publishing results
Plan to share: Yes — IPD Sharing can be done after written official request in Sechenov University and approval of Central Contact investigator because our local Ethics committee does not allow free study sharing.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
I.M. Sechenov First Moscow State Medical University