Clinical trial NCT05872594: Prevalence of a Phenomenon of Epic Dream Disorder
Official title: Assessing the Prevalence and Associated Risk Factors of a Phenomenon of Epic Dream Disorder: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dream Disorder
Keywords: dream
epic dream disorder
daytime symptoms
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Conditionally healthy individuals expressing their interest to participate by clicking the link to the questionnaires and informed consent form that will be spreaded in social media, student communities, and university departmental staff communities

Brief summary: A single-center, cross-sectional, non-interventional study based on the sleep department of the Kozhevnikov Clinic for Nervous Diseases at Sechenov University. A.Y. Kozhevnikov Sechenov University is being conducted between September 2022 and December 2023 to assess the prevalence and associated symptoms and risk factors of a multiple dreams with vivid emotion, causing morning and daytime symptoms - phenomenon of Epic Dream Disorder (EDD). Demographic, sleep and psychological characteristics of people with multiple dreams will be identified, including the following standardized scales: Spielberger Anxiety Scale, Beck Depression Scale, Shortened Sleep Questionnaire. Data will be collected by mean of online questionnaire tool. According to the data obtained, prevalence of the phenomenon, differences between continuous, rank and categorical variables will be calculated in participants with and without EDD. Multivariate logistic regression will be performed to assess associated risk factors of EDD.

Detailed description: In clinical practice, there are patients complaining for numerous dreams, which negatively affect the daytime well-being of patients, although these complaints do not fall into the category of nightmares. There are currently no data on the prevalence of the phenomenon of this phenomenon. Studies conducted on small groups of patients have found that they are more likely to have chronic pain syndrome, family history of their complaints.

The proposed study will be able to provide the first data on the prevalence and concomitant symptoms of multiple dreams. This will allow the authors to give a more precise definition of this phenomenon, describe its concomitant symptoms, and evaluate the relevance of its diagnosis and treatment. The results of the study will set the stage for further clinical research on the pathogenesis and therapy approaches. The further studies are needed to explain the causes of this phenomenon to the patients and provide them with the necessary assistance.

In view of the high workload of the medical staff, and clinical centers under the COVID-19 pandemic, and in order to increase convenience for both study participants and the researchers, data for this study will be collected remotely. The implementation of the study objectives did not require a face-to-face examination of the participants. Internet-based data collection will further simplify the processing of the data. This approach to conducting the study has already shown its applicability in a number of clinical trials.

The study will be conducted at the I.M. Sechenov First Moscow State Medical University, Russian Ministry of Health, UTH No. 3, Clinic of Nervous Diseases. A.Y. Kozhevnikov, Department of Sleep Medicine.

This study plans to inсlude all participants who agreed to participate (i.e., who clicked on the button "agree" after reading informed consent form). Information about the study and link to the questionnaires and informed consent form will be spreaded in social media, student communities, and university departmental staff communities The demographic, sleep, and psychological characteristics of people with multiple dreams will be assessed. Then a statistical analysis will be performed to compare the differences in rank, continuous, and categorical variables, and perform a multivariate logistic regression.

Eligibility criteria: Inclusion Criteria:

* consent to participate in the study, expressed by ticking the appropriate box on the website after reading the text of the informed consent, confirming their understanding of the study and their consent to participate in it;

Exclusion Criteria:

* age \< 18 years; This criterion is evaluated when completing the questionnaire, questionnaires from participants under 18 years old will not be included in the statistical analysis

Primary outcomes:
measure: Prevalence of the phenomenon of epic dream disorder
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Demographic outcomes: Sex
timeFrame: Through study completion, an average of 1 year
measure: Demographic outcomes: Age
timeFrame: Through study completion, an average of 1 year
measure: Demographic outcomes: Weight
timeFrame: Through study completion, an average of 1 year
measure: Demographic outcomes: Height
timeFrame: Through study completion, an average of 1 year
measure: Demographic outcomes: Level of education
timeFrame: Through study completion, an average of 1 year
measure: Demographic outcomes: name the University
timeFrame: Through study completion, an average of 1 year
measure: Demographic outcomes: name your department
timeFrame: Through study completion, an average of 1 year
measure: Demographic outcomes: year of study
timeFrame: Through study completion, an average of 1 year
measure: Demographic outcomes: Employment status
timeFrame: Through study completion, an average of 1 year
measure: use of nicotine
timeFrame: Through study completion, an average of 1 year
measure: use of alcohol
timeFrame: Through study completion, an average of 1 year
measure: Medical history
timeFrame: Through study completion, an average of 1 year
measure: duration of complaints
timeFrame: Through study completion, an average of 1 year
measure: Average duration of sleep
timeFrame: Through study completion, an average of 1 year
measure: dreams during daytime nap
timeFrame: Through study completion, an average of 1 year
measure: Amount of dreams during the night
timeFrame: Through study completion, an average of 1 year
measure: discomfort after the night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: triggers of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Intensity of thought activity in dream
timeFrame: Through study completion, an average of 1 year
measure: Intensity of speech activity in dream
timeFrame: Through study completion, an average of 1 year
measure: Intensity of running in dream
timeFrame: Through study completion, an average of 1 year
measure: Intensity of walking in dream
timeFrame: Through study completion, an average of 1 year
measure: Intensity of monotonous physical movements in dream
timeFrame: Through study completion, an average of 1 year
measure: Intensity of flight in dream
timeFrame: Through study completion, an average of 1 year
measure: Intensity of swimming in dream
timeFrame: Through study completion, an average of 1 year
measure: Intensity of jumping in dream
timeFrame: Through study completion, an average of 1 year
measure: Intensity of trip by transport in dream
timeFrame: Through study completion, an average of 1 year
measure: recalling dreams upon awakening
timeFrame: Through study completion, an average of 1 year
measure: characteristics of dream content
timeFrame: Through study completion, an average of 1 year
measure: characteristics of dream content
timeFrame: Through study completion, an average of 1 year
measure: Impression that your brain stays awake while you sleep
timeFrame: Through study completion, an average of 1 year
measure: Any peculiarities of your dream
timeFrame: Through study completion, an average of 1 year
measure: Awareness of a dream
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Subjective symptoms in the morning after a night of active dreaming
timeFrame: Through study completion, an average of 1 year
measure: Use of medications
timeFrame: Through study completion, an average of 1 year
measure: Dose of medications
timeFrame: Through study completion, an average of 1 year
measure: Frequency of medications
timeFrame: Through study completion, an average of 1 year
measure: awakenings during the night
timeFrame: Through study completion, an average of 1 year
measure: Frequency of nights with multiple dreams
timeFrame: Through study completion, an average of 1 year
measure: Seasonal fluctuation of the multiple dreams
timeFrame: Through study completion, an average of 1 year
measure: Family history of Excessive dream disorder
timeFrame: Through study completion, an average of 1 year
measure: Depression symptoms
timeFrame: Through study completion, an average of 1 year
measure: State anxiety symptoms
timeFrame: Through study completion, an average of 1 year
measure: Trait anxiety symptoms
timeFrame: Through study completion, an average of 1 year
measure: Shortened Sleep Questionnaire
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: II.M. Sechenov First Moscow State Medical University (Sechenov University)
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Mikhail Poluektov, PhD
role: STUDY_DIRECTOR
affiliation: I.M. Sechenov First Moscow State Medical University (Sechenov University)
name: Polina Pchelina, PhD
role: PRINCIPAL_INVESTIGATOR
References: