Prevalence of a Phenomenon of Epic Dream Disorder

Dream Disorder Clinical Trial

Official title:

Assessing the Prevalence and Associated Risk Factors of a Phenomenon of Epic Dream Disorder: a Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872594
• Other study ID #: 0000640001
• Status: Recruiting
• Start date: September 30, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2023
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Polina Pchelina, PhD
• Phone: +79036701725
• Email: polbox[@]mail.ru, pchelina_p_v[@]staff.sechenov.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Dream Disorder

Intervention

Diagnostic Test:
• Online questionnaire
data will be collected remotely on the online platform Qualtrics

Locations

Country	Name	City	State
Russian Federation	II.M. Sechenov First Moscow State Medical University (Sechenov University)	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of the phenomenon of epic dream disorder	prevalence of the disease - the proportion of participants with the diagnosed epic dream disorder to the whole sample	Through study completion, an average of 1 year
Secondary	Demographic outcomes: Sex	options (male, female)	Through study completion, an average of 1 year
Secondary	Demographic outcomes: Age	Age in years	Through study completion, an average of 1 year
Secondary	Demographic outcomes: Weight	Weight in kg	Through study completion, an average of 1 year
Secondary	Demographic outcomes: Height	Height in cm	Through study completion, an average of 1 year
Secondary	Demographic outcomes: Level of education	choose category for the level of education	Through study completion, an average of 1 year
Secondary	Demographic outcomes: name the University	For students only	Through study completion, an average of 1 year
Secondary	Demographic outcomes: name your department	For students only	Through study completion, an average of 1 year
Secondary	Demographic outcomes: year of study	For students only	Through study completion, an average of 1 year
Secondary	Demographic outcomes: Employment status	choose category for the employment status and specify your scope of activities if any	Through study completion, an average of 1 year
Secondary	use of nicotine	Fact and frequency of use of nicotine	Through study completion, an average of 1 year
Secondary	use of alcohol	Fact and frequency of use of alcohol	Through study completion, an average of 1 year
Secondary	Medical history	Presence of any chronic illnesses (specify the name)	Through study completion, an average of 1 year
Secondary	duration of complaints	Question: how long do you experience multiple dreams	Through study completion, an average of 1 year
Secondary	Average duration of sleep	hours	Through study completion, an average of 1 year
Secondary	dreams during daytime nap	Presence of dreams during daytime nap (yes or no)	Through study completion, an average of 1 year
Secondary	Amount of dreams during the night	specify number (0, 1, 2, 3 and more)	Through study completion, an average of 1 year
Secondary	discomfort after the night of active dreaming	Presence of discomfort after the night of active dreaming in the morning or during the day	Through study completion, an average of 1 year
Secondary	triggers of active dreaming	Were you able to identify a factor or event that triggered the appearance of multiple dreams? If yes, specify.	Through study completion, an average of 1 year
Secondary	Intensity of thought activity in dream	range 1-5	Through study completion, an average of 1 year
Secondary	Intensity of speech activity in dream	range 1-5	Through study completion, an average of 1 year
Secondary	Intensity of running in dream	range 1-5	Through study completion, an average of 1 year
Secondary	Intensity of walking in dream	range 1-5	Through study completion, an average of 1 year
Secondary	Intensity of monotonous physical movements in dream	range 1-5	Through study completion, an average of 1 year
Secondary	Intensity of flight in dream	range 1-5	Through study completion, an average of 1 year
Secondary	Intensity of swimming in dream	range 1-5	Through study completion, an average of 1 year
Secondary	Intensity of jumping in dream	range 1-5	Through study completion, an average of 1 year
Secondary	Intensity of trip by transport in dream	range 1-5	Through study completion, an average of 1 year
Secondary	recalling dreams upon awakening	Question: After waking up, do you remember what you saw in the dream? with 3 options - I remember that I had a dream, but I don't remember what it was about; I remember what the dream was about; I remember all the details of the dream	Through study completion, an average of 1 year
Secondary	characteristics of dream content	Intensity of positive emotions (range 1-5)	Through study completion, an average of 1 year
Secondary	characteristics of dream content	Intensity of negative emotions (range 1-5)	Through study completion, an average of 1 year
Secondary	Impression that your brain stays awake while you sleep	range 1-5	Through study completion, an average of 1 year
Secondary	Any peculiarities of your dream	specify	Through study completion, an average of 1 year
Secondary	Awareness of a dream	I don't realize I'm dreaming; I am aware that I am dreaming, but I have no control; Awareness of dreaming and controlling; I realize that I'm dreaming and I can change the plot	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptome Having difficulty knowing whether something happened in the dream or in reality	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom the feeling you had in the dream persists during the wakefulness for more than a few seconds	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Heart palpitations	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Shortness of breath	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Hyperhidrosis	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom feeling Cold	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Fatigue	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Bad mood	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Muscle pain	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Headache	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Pain in chest	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Balance disturbance	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Loss of tactile sensitivity	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Tingling/frowning sensation	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Anxiety	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Weakness	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the symptom Nausea	Through study completion, an average of 1 year
Secondary	Subjective symptoms in the morning after a night of active dreaming	Presence and length of the other symptoms, if any	Through study completion, an average of 1 year
Secondary	Use of medications	Question about the use of medication, no or yes (specify the name)	Through study completion, an average of 1 year
Secondary	Dose of medications	Question about the dose of medication, if any	Through study completion, an average of 1 year
Secondary	Frequency of medications	Question about the frequency of medications use, if any	Through study completion, an average of 1 year
Secondary	awakenings during the night	Number of awakenings during the night	Through study completion, an average of 1 year
Secondary	Frequency of nights with multiple dreams	Number of nights per week	Through study completion, an average of 1 year
Secondary	Seasonal fluctuation of the multiple dreams	During which season do the multiple dreams occur more often	Through study completion, an average of 1 year
Secondary	Family history of Excessive dream disorder	Did any of your family members has the same complaints, if yes, specify	Through study completion, an average of 1 year
Secondary	Depression symptoms	Beck Depression scale	Through study completion, an average of 1 year
Secondary	State anxiety symptoms	State anxiety by Spielberger Anxiety Scale	Through study completion, an average of 1 year
Secondary	Trait anxiety symptoms	Trait anxiety by Spielberger Anxiety Scale	Through study completion, an average of 1 year
Secondary	Shortened Sleep Questionnaire	Validated questionnaire to evaluate insomniac complaints, parasomnias, use of medications, hypersomnias, sleep related breathe disorders	Through study completion, an average of 1 year