Narcolepsy Type 1NCT05375890

Clinical and Neurophysiological Characteristics of Narcolepsy

An observational study of Narcolepsy Type 1, run by I.M. Sechenov First Moscow State Medical University at 11 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 7 to 78 years
Conditions the study is for: Narcolepsy Type 1
How many people: 89 participants
Where: 11 sitesRussia
Study dates: 1 Nov 2019to 28 Sep 2023
How long will I take part?: 1 Month
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 7 to 78 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 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.

Who may be able to join

Signed written informed consent of the patient and/or parent/adoptive parent (in the case of a minor) to participate in the study;
Age: 6-80 years;
Gender: Men and women;
Established diagnosis: Narcolepsy of type I and II (according to the criteria of the International classification of sleep disorders of 2014).

Who cannot join

Refusal of the patient or his parent / adoptive parent (in the case of a minor) from further participation in the study;
The occurrence of a serious illness or a significant deterioration of a disease unrelated to narcolepsy;
Pregnancy started after inclusion.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Russia11 sites

Regional Clinical Hospital No.3
Chelyabinsk
Kazan State Medical University
Kazan'
Private healthcare institution 'Clinical hospital 'RZD-Medicine'
Khabarovsk
Burnasyan Federal Medical Biophysical Center of Federal Medical Biological Agency
Moscow
FSBI NMRCO FMBA Russia
Moscow
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
Novosibirsk State Medical University
Novosibirsk
Almazov National Medical Research Centre
Saint Petersburg
Nikiforov Russian Center of Emergency and Radiation Medicine, EMERCOM of Russia
Saint Petersburg
V. M. Bekhterev National Research Medical Center for Psychiatry and Neurology
Saint Petersburg
Samara State Medical University
Samara

Other trials in Russia

About this study

Official title: Clinical and Neurophysiological Characteristics of Narcolepsy in Russia Basing on Clinical, Polysomnographic and Genome-wide Association Analyses of Narcolepsy With Cataplexy: a European Narcolepsy Network Study of 2013

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.

Read the detailed 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:

Demographic characteristics: date of birth, gender, height, weight, BMI(body mass index) at diagnosis.
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.
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.
ESS (Epworth Sleepiness Scale) score at diagnosis.
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.
Associated features, with particular attention to symptoms frequently reported with narcolepsy: sleep paralysis (SP); hypnagogic/hypnopompic hallucinations (HH); and poor nocturnal sleep.
Co-morbidities (sleep-related, somatic or psychiatric) and treatment when available.

Conditions: Narcolepsy Type 1
Being tested: no intervention
Keywords: narcolepsy, cataplexy, excessive sleepiness, PSG, MSLT, Russia
Medical subject headings: Narcolepsy, Cataplexy, Disorders of Excessive Somnolence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

no interventionOther
Narcolepsy patients in Russia gathered according to criteria.

What is being measured

The primary outcome is the main question the study is designed to answer.

date of birth
year of birth
Measured: during 1-3 years after beginning and when patient and data are available
gender
male or female
Measured: during 1-3 years after beginning and when patient and data are available
height
meters
Measured: during 1-3 years after beginning and when patient and data are available
weight
kilograms
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: during 1-3 years after beginning and when patient and data are available
ESS score at diagnosis
Unit of Measure at diagnosis
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: during 1-3 years after beginning and when patient and data are available

Secondary outcomes (1)

summarization of collected database with European one
analyzing and comparison collected data with European one leading to final summarization of studying
Measured: 1 year after receiving data from sleep centers from Russia and publishing results

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201928 Sep 2023

First posted17 May 2022
Study start1 Nov 2019
Primary completion1 Feb 2022
Study completion28 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
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: Prospective
Enrolment: 89 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT05375890
Sponsor's protocol ID: 246188
Status last verified: May 2022
First submitted: 4 May 2022
Last updated: 13 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Kuts A, Poluektov M, Bassetti CLA. The evolution of the narcolepsy concept in Russia: A historical view. J Hist Neurosci. 2021 Apr-Jun;30(2):113-127. doi: 10.1080/0964704X.2020.1777502. Epub 2020 Jun 30.
PubMed 32603636
Kuts A, Poluektov M, Zakharov A, Govzman V, Ponomareva I, Yakupov E, Zavalko I, Tikhomirova O, Sviryaev Y, Yakovlev A, Polyakov A, Melnikov A, Bassetti CLA. Clinical and neurophysiological characteristics of 89 patients with narcolepsy and cataplexy from the Russian Narcolepsy Network. J Clin Sleep Med. 2023 Feb 1;19(2):355-359. doi: 10.5664/jcsm.10340.
PubMed 36305577

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Neurophysiological Characteristics of Narcolepsy in Russia Basing on Clinical, Polysomnographic and Genome-wide Association Analyses of Narcolepsy With Cataplexy: a European Narcolepsy Network Study of 2013
ClinicalTrials.gov ID: NCT05375890
Acronym / sponsor ID: 246188
Conditions: Narcolepsy Type 1
Keywords: narcolepsy, cataplexy, excessive sleepiness, PSG, MSLT, Russia
Study type: Observational
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
Study start: 1 Nov 2019 (actual)
Primary completion: 1 Feb 2022 (actual)
Study completion: 28 Sep 2023 (actual)
First posted: 17 May 2022 (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.

Detailed description

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.

Demographic characteristics: date of birth, gender, height, weight, BMI(body mass index) at diagnosis.
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.
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.
ESS (Epworth Sleepiness Scale) score at diagnosis.
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.
Associated features, with particular attention to symptoms frequently reported with narcolepsy: sleep paralysis (SP); hypnagogic/hypnopompic hallucinations (HH); and poor nocturnal sleep.
Co-morbidities (sleep-related, somatic or psychiatric) and treatment when available.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Month

Who may qualify

Ages: 7 to 78 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 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.

Key inclusion criteria (4 listed)

Signed written informed consent of the patient and/or parent/adoptive parent (in the case of a minor) to participate in the study;
Age: 6-80 years;
Gender: Men and women;
Established diagnosis: Narcolepsy of type I and II (according to the criteria of the International classification of sleep disorders of 2014).

Key exclusion criteria (3 listed)

Refusal of the patient or his parent / adoptive parent (in the case of a minor) from further participation in the study;
The occurrence of a serious illness or a significant deterioration of a disease unrelated to narcolepsy;
Pregnancy started after inclusion.

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
no interventionNarcolepsy patients in Russia gathered according to criteria.	Other	–

Primary outcome

date of birth
Time frame: during 1-3 years after beginning and when patient and data are available
year of birth
gender
Time frame: during 1-3 years after beginning and when patient and data are available
male or female
height
Time frame: during 1-3 years after beginning and when patient and data are available
meters
weight
Time frame: during 1-3 years after beginning and when patient and data are available
kilograms
BMI at diagnosis
Time frame: during 1-3 years after beginning and when patient and data are available
Weight and height will be combined to report BMI in kg/m^2 at the time of diagnosis
age at EDS (excessive daytime sleepioness) onset
Time frame: during 1-3 years after beginning and when patient and data are available
Age when EDS first time was reported by patient
age at cataplexy onset
Time frame: during 1-3 years after beginning and when patient and data are available
Age when cataplexy first time was reported by patient
frequency of cataplexy attacks at diagnosis
Time frame: during 1-3 years after beginning and when patient and data are available
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.
ESS score at diagnosis
Time frame: during 1-3 years after beginning and when patient and data are available
Unit of Measure at diagnosis
Apnea-hypopnea index (AHI)
Time frame: during 1-3 years after beginning and when patient and data are available
PSG at diagnosis, Unit of Measure at diagnosis
Periodic leg movements during sleep index (PLMSI)
Time frame: during 1-3 years after beginning and when patient and data are available
Number of episodes and hours of sleep combined to report PLMSI in episodes per hour.
Sleep onset latency at diagnosis
Time frame: during 1-3 years after beginning and when patient and data are available
Time from lights off to the first epoch scored as sleep in PSG. Measured in minutes.
Sleep latency
Time frame: during 1-3 years after beginning and when patient and data are available
Time from lights off to the first epoch scored as sleep in MSLT. Measured in minutes.
Number of SOREM
Time frame: during 1-3 years after beginning and when patient and data are available
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.
Frequently of sleep paralysis, hypnagogic/hypnopompic hallucinations and poor nocturnal sleep, co-morbidities (sleep-related, somatic or psychiatric) and treatment when available.
Time frame: during 1-3 years after beginning and when patient and data are available
Percentage of occurence in group.

1 secondary outcome

summarization of collected database with European one
Time frame: 1 year after receiving data from sleep centers from Russia and publishing results

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 13 Mar 2024.
Background: PubMed 32603636Kuts A, Poluektov M, Bassetti CLA. The evolution of the narcolepsy concept in Russia: A historical view. J Hist Neurosci. 2021 Apr-Jun;30(2):113-127. doi: 10.1080/0964704X.2020.1777502. Epub 2020 Jun 30.
Derived from this study: PubMed 36305577Kuts A, Poluektov M, Zakharov A, Govzman V, Ponomareva I, Yakupov E, Zavalko I, Tikhomirova O, Sviryaev Y, Yakovlev A, Polyakov A, Melnikov A, Bassetti CLA. Clinical and neurophysiological characteristics of 89 patients with narcolepsy and cataplexy from the Russian Narcolepsy Network. J Clin Sleep Med. 2023 Feb 1;19(2):355-359. doi: 10.5664/jcsm.10340.
Official website of Russian narcolepsy networkLink provided by the sponsor.
Individual participant dataSharing planned: 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.

Related trials for Narcolepsy Type 1

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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.

Alexander Kuts principal investigator

I.M. Sechenov First Moscow State Medical University (Sechenov University)

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Narcolepsy Type 1, run by I.M. Sechenov First Moscow State Medical University at 11 sites in Russia.

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 4 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: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Russia. 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?

date of birth (time frame: during 1-3 years after beginning and when patient and data are available). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05375890, which also lists 2 linked publications.

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 13 Mar 2024.