Clinical and Neurophysiological Characteristics of Narcolepsy

NCT05375890 | Completed

• 1 other identifier: 246188
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Narcolepsy Type 1

Keywords

narcolepsy; cataplexy; excessive sleepiness; PSG; MSLT; Russia

Outcome Measures

Primary Outcomes (15)

• date of birth

  year of birth

  during 1-3 years after beginning and when patient and data are available

• gender

  male or female

  during 1-3 years after beginning and when patient and data are available

• height

  meters

  during 1-3 years after beginning and when patient and data are available

• weight

  kilograms

  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

  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

  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

  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.

  during 1-3 years after beginning and when patient and data are available

• ESS score at diagnosis

  Unit of Measure at diagnosis

  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

  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.

  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.

  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.

  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.

  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.

  during 1-3 years after beginning and when patient and data are available

Secondary Outcomes (1)

• summarization of collected database with European one

  1 year after receiving data from sleep centers from Russia and publishing results

Interventions

no intervention OTHER

Narcolepsy patients in Russia gathered according to criteria.

Eligibility Criteria

• Age: 7 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (11)

Regional Clinical Hospital No.3

Chelyabinsk, Russia

Location

Kazan State Medical University

Kazan', Russia

Location

Private healthcare institution 'Clinical hospital 'RZD-Medicine'

Khabarovsk, Russia

Location

Burnasyan Federal Medical Biophysical Center of Federal Medical Biological Agency

Moscow, Russia

Location

FSBI NMRCO FMBA Russia

Moscow, Russia

Location

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

Moscow, Russia

Location

Novosibirsk State Medical University

Novosibirsk, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, Russia

Location

Nikiforov Russian Center of Emergency and Radiation Medicine, EMERCOM of Russia

Saint Petersburg, Russia

Location

V. M. Bekhterev National Research Medical Center for Psychiatry and Neurology

Saint Petersburg, Russia

Location

Samara State Medical University

Samara, Russia

Location

Related Publications (2)

• 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.

  PMID: 32603636 BACKGROUND

• 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.

  PMID: 36305577 DERIVED

Related Links

• Official website of Russian narcolepsy network

MeSH Terms

Conditions

Narcolepsy; Cataplexy; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Alexander Kuts

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 17, 2022
• Study Start: November 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: September 28, 2023
• Last Updated: March 13, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: After official request and approval the data will become available with an indication of the terms of use.
• Access Criteria: Our Ethics committee does not approve free study sharing. We can provide it only after written official request in Sechenov University and approval of Central Contact investigator.

Locations

RU (11)