- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05872594
Prevalence of a Phenomenon of Epic Dream Disorder
Assessing the Prevalence and Associated Risk Factors of a Phenomenon of Epic Dream Disorder: a Cross-sectional Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Polina Pchelina, PhD
- Phone Number: +79036701725
- Email: polbox@mail.ru, pchelina_p_v@staff.sechenov.ru
Study Contact Backup
- Name: Mikhail Rumyantsev
Study Locations
-
-
-
Moscow, Russian Federation
- Recruiting
- II.M. Sechenov First Moscow State Medical University (Sechenov University)
-
Contact:
- Mikhail Poluektov, PhD
-
Sub-Investigator:
- Polina Pchelina, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
study group
all participants older than 18 years who agreed to participate (i.e., who clicked on the button "agree" after reading informed consent form) with no regard to sex, race, education, family status
|
data will be collected remotely on the online platform Qualtrics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of the phenomenon of epic dream disorder
Time Frame: Through study completion, an average of 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic outcomes: Sex
Time Frame: Through study completion, an average of 1 year
|
options (male, female)
|
Through study completion, an average of 1 year
|
|
Demographic outcomes: Age
Time Frame: Through study completion, an average of 1 year
|
Age in years
|
Through study completion, an average of 1 year
|
|
Demographic outcomes: Weight
Time Frame: Through study completion, an average of 1 year
|
Weight in kg
|
Through study completion, an average of 1 year
|
|
Demographic outcomes: Height
Time Frame: Through study completion, an average of 1 year
|
Height in cm
|
Through study completion, an average of 1 year
|
|
Demographic outcomes: Level of education
Time Frame: Through study completion, an average of 1 year
|
choose category for the level of education
|
Through study completion, an average of 1 year
|
|
Demographic outcomes: name the University
Time Frame: Through study completion, an average of 1 year
|
For students only
|
Through study completion, an average of 1 year
|
|
Demographic outcomes: name your department
Time Frame: Through study completion, an average of 1 year
|
For students only
|
Through study completion, an average of 1 year
|
|
Demographic outcomes: year of study
Time Frame: Through study completion, an average of 1 year
|
For students only
|
Through study completion, an average of 1 year
|
|
Demographic outcomes: Employment status
Time Frame: Through study completion, an average of 1 year
|
choose category for the employment status and specify your scope of activities if any
|
Through study completion, an average of 1 year
|
|
use of nicotine
Time Frame: Through study completion, an average of 1 year
|
Fact and frequency of use of nicotine
|
Through study completion, an average of 1 year
|
|
use of alcohol
Time Frame: Through study completion, an average of 1 year
|
Fact and frequency of use of alcohol
|
Through study completion, an average of 1 year
|
|
Medical history
Time Frame: Through study completion, an average of 1 year
|
Presence of any chronic illnesses (specify the name)
|
Through study completion, an average of 1 year
|
|
duration of complaints
Time Frame: Through study completion, an average of 1 year
|
Question: how long do you experience multiple dreams
|
Through study completion, an average of 1 year
|
|
Average duration of sleep
Time Frame: Through study completion, an average of 1 year
|
hours
|
Through study completion, an average of 1 year
|
|
dreams during daytime nap
Time Frame: Through study completion, an average of 1 year
|
Presence of dreams during daytime nap (yes or no)
|
Through study completion, an average of 1 year
|
|
Amount of dreams during the night
Time Frame: Through study completion, an average of 1 year
|
specify number (0, 1, 2, 3 and more)
|
Through study completion, an average of 1 year
|
|
discomfort after the night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence of discomfort after the night of active dreaming in the morning or during the day
|
Through study completion, an average of 1 year
|
|
triggers of active dreaming
Time Frame: Through study completion, an average of 1 year
|
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
|
|
Intensity of thought activity in dream
Time Frame: Through study completion, an average of 1 year
|
range 1-5
|
Through study completion, an average of 1 year
|
|
Intensity of speech activity in dream
Time Frame: Through study completion, an average of 1 year
|
range 1-5
|
Through study completion, an average of 1 year
|
|
Intensity of running in dream
Time Frame: Through study completion, an average of 1 year
|
range 1-5
|
Through study completion, an average of 1 year
|
|
Intensity of walking in dream
Time Frame: Through study completion, an average of 1 year
|
range 1-5
|
Through study completion, an average of 1 year
|
|
Intensity of monotonous physical movements in dream
Time Frame: Through study completion, an average of 1 year
|
range 1-5
|
Through study completion, an average of 1 year
|
|
Intensity of flight in dream
Time Frame: Through study completion, an average of 1 year
|
range 1-5
|
Through study completion, an average of 1 year
|
|
Intensity of swimming in dream
Time Frame: Through study completion, an average of 1 year
|
range 1-5
|
Through study completion, an average of 1 year
|
|
Intensity of jumping in dream
Time Frame: Through study completion, an average of 1 year
|
range 1-5
|
Through study completion, an average of 1 year
|
|
Intensity of trip by transport in dream
Time Frame: Through study completion, an average of 1 year
|
range 1-5
|
Through study completion, an average of 1 year
|
|
recalling dreams upon awakening
Time Frame: Through study completion, an average of 1 year
|
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
|
Through study completion, an average of 1 year
|
|
characteristics of dream content
Time Frame: Through study completion, an average of 1 year
|
Intensity of positive emotions (range 1-5)
|
Through study completion, an average of 1 year
|
|
characteristics of dream content
Time Frame: Through study completion, an average of 1 year
|
Intensity of negative emotions (range 1-5)
|
Through study completion, an average of 1 year
|
|
Impression that your brain stays awake while you sleep
Time Frame: Through study completion, an average of 1 year
|
range 1-5
|
Through study completion, an average of 1 year
|
|
Any peculiarities of your dream
Time Frame: Through study completion, an average of 1 year
|
specify
|
Through study completion, an average of 1 year
|
|
Awareness of a dream
Time Frame: Through study completion, an average of 1 year
|
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
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
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
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
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
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Heart palpitations
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Shortness of breath
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Hyperhidrosis
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom feeling Cold
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Fatigue
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Bad mood
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Muscle pain
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Headache
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Pain in chest
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Balance disturbance
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Loss of tactile sensitivity
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Tingling/frowning sensation
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Anxiety
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Weakness
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the symptom Nausea
|
Through study completion, an average of 1 year
|
|
Subjective symptoms in the morning after a night of active dreaming
Time Frame: Through study completion, an average of 1 year
|
Presence and length of the other symptoms, if any
|
Through study completion, an average of 1 year
|
|
Use of medications
Time Frame: Through study completion, an average of 1 year
|
Question about the use of medication, no or yes (specify the name)
|
Through study completion, an average of 1 year
|
|
Dose of medications
Time Frame: Through study completion, an average of 1 year
|
Question about the dose of medication, if any
|
Through study completion, an average of 1 year
|
|
Frequency of medications
Time Frame: Through study completion, an average of 1 year
|
Question about the frequency of medications use, if any
|
Through study completion, an average of 1 year
|
|
awakenings during the night
Time Frame: Through study completion, an average of 1 year
|
Number of awakenings during the night
|
Through study completion, an average of 1 year
|
|
Frequency of nights with multiple dreams
Time Frame: Through study completion, an average of 1 year
|
Number of nights per week
|
Through study completion, an average of 1 year
|
|
Seasonal fluctuation of the multiple dreams
Time Frame: Through study completion, an average of 1 year
|
During which season do the multiple dreams occur more often
|
Through study completion, an average of 1 year
|
|
Family history of Excessive dream disorder
Time Frame: Through study completion, an average of 1 year
|
Did any of your family members has the same complaints, if yes, specify
|
Through study completion, an average of 1 year
|
|
Depression symptoms
Time Frame: Through study completion, an average of 1 year
|
Beck Depression scale
|
Through study completion, an average of 1 year
|
|
State anxiety symptoms
Time Frame: Through study completion, an average of 1 year
|
State anxiety by Spielberger Anxiety Scale
|
Through study completion, an average of 1 year
|
|
Trait anxiety symptoms
Time Frame: Through study completion, an average of 1 year
|
Trait anxiety by Spielberger Anxiety Scale
|
Through study completion, an average of 1 year
|
|
Shortened Sleep Questionnaire
Time Frame: Through study completion, an average of 1 year
|
Validated questionnaire to evaluate insomniac complaints, parasomnias, use of medications, hypersomnias, sleep related breathe disorders
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Study Director: Mikhail Poluektov, PhD, I.M. Sechenov First Moscow State Medical University (Sechenov University)
- Principal Investigator: Polina Pchelina, PhD, I.M. Sechenov First Moscow State Medical University (Sechenov University)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000640001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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