CompletedNot Applicable

Clinical and Neurophysiological Characteristics of Narcolepsy

Russia89 participantsStarted 2019-11-01

Plain-language 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.

Who can participate

Age range

7 Years – 78 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

date of birth

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

gender

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

height

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

weight

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

BMI at diagnosis

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

age at EDS (excessive daytime sleepioness) onset

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

age at cataplexy onset

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

Trial details

NCT IDNCT05375890

SponsorI.M. Sechenov First Moscow State Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-02-01

View on ClinicalTrials.gov More Narcolepsy Type 1 trials

Plain-language summary

Who can participate

Age range

7 Years – 78 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

. 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;

What they're measuring

date of birth

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

gender

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

height

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

weight

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

BMI at diagnosis

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

age at EDS (excessive daytime sleepioness) onset

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

age at cataplexy onset

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