Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05375890 |
Other study ID # |
246188 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 1, 2019 |
Est. completion date |
September 28, 2023 |
Study information
Verified date |
May 2022 |
Source |
I.M. Sechenov First Moscow State Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
Description:
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:
1. Demographic characteristics: date of birth, gender, height, weight, BMI(body mass index)
at diagnosis.
2. Age at EDS (excessive daytime sleepines) onset and age at cataplexy onset. Investigators
defined the age at onset of NC(narcolepsy with cataplexy) as the age at occurrence of
EDS and/or cataplexy, determined during the clinical interview.
3. Frequency of cataplexy attacks 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.
4. ESS (Epworth Sleepiness Scale) score at diagnosis.
5. Polysomnographic variables [sleep onset latency at diagnosis, apnea-hypopnea index (AHI)
and periodic leg movements during sleep index (PLMSI) when available] and MSLT results
(mean sleep latency, number of SOREMPs) at diagnosis. Even if the recording procedures
were different among centers, most of the patients underwent nocturnal in-lab PSG
followed by an MSLT as part of the diagnostic evaluation. For PSG and MSLT, sleep
latency was defined as the time from lights off to the first epoch scored as sleep. A
SOREMP was defined as the occurrence of an epoch of REM(rapid eye movement) sleep within
15 min after the first epoch scored as sleep. Although MSLT was performed according to
standard methods (Carskadon MA, Dement WC, Mitler MM, Roth T, Westbrook PR, Keenan S.
Guidelines for the multiple sleep latency test (MSLT): a standard measure of sleepiness.
Sleep. 1986 Dec;9(4):519-24. doi: 10.1093/sleep/9.4.519. PMID: 3809866.), the number of
scheduled naps could be variable. To standardize the results, investigators calculated
the percentage of SOREMPs of the total number of naps: percentage of naps with SOREMPs.
7. Associated features, with particular attention to symptoms frequently reported with
narcolepsy: sleep paralysis (SP); hypnagogic/hypnopompic hallucinations (HH); and poor
nocturnal sleep.
8. Co-morbidities (sleep-related, somatic or psychiatric) and treatment when available.