Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT05872594
Status:
UNKNOWN
Last Update Posted:
2023-05-24
First Post:
2022-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of a Phenomenon of Epic Dream Disorder
Sponsor:
Organization:
Raw JSON
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If yes, specify.'}, {'measure': 'Intensity of thought activity in dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'range 1-5'}, {'measure': 'Intensity of speech activity in dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'range 1-5'}, {'measure': 'Intensity of running in dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'range 1-5'}, {'measure': 'Intensity of walking in dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'range 1-5'}, {'measure': 'Intensity of monotonous physical movements in dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'range 1-5'}, {'measure': 'Intensity of flight in dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'range 1-5'}, {'measure': 'Intensity of swimming in dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'range 1-5'}, {'measure': 'Intensity of jumping in dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'range 1-5'}, {'measure': 'Intensity of trip by transport in dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'range 1-5'}, {'measure': 'recalling dreams upon awakening', 'timeFrame': 'Through study completion, an average of 1 year', 'description': "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\n\n* I remember what the dream was about\n* I remember all the details of the dream"}, {'measure': 'characteristics of dream content', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Intensity of positive emotions (range 1-5)'}, {'measure': 'characteristics of dream content', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Intensity of negative emotions (range 1-5)'}, {'measure': 'Impression that your brain stays awake while you sleep', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'range 1-5'}, {'measure': 'Any peculiarities of your dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'specify'}, {'measure': 'Awareness of a dream', 'timeFrame': 'Through study completion, an average of 1 year', 'description': "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"}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptome Having difficulty knowing whether something happened in the dream or in reality'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom the feeling you had in the dream persists during the wakefulness for more than a few seconds'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Heart palpitations'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Shortness of breath'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Hyperhidrosis'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom feeling Cold'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Fatigue'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Bad mood'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Muscle pain'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Headache'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Pain in chest'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Balance disturbance'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Loss of tactile sensitivity'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Tingling/frowning sensation'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Anxiety'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Weakness'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the symptom Nausea'}, {'measure': 'Subjective symptoms in the morning after a night of active dreaming', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence and length of the other symptoms, if any'}, {'measure': 'Use of medications', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Question about the use of medication, no or yes (specify the name)'}, {'measure': 'Dose of medications', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Question about the dose of medication, if any'}, {'measure': 'Frequency of medications', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Question about the frequency of medications use, if any'}, {'measure': 'awakenings during the night', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of awakenings during the night'}, {'measure': 'Frequency of nights with multiple dreams', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of nights per week'}, {'measure': 'Seasonal fluctuation of the multiple dreams', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'During which season do the multiple dreams occur more often'}, {'measure': 'Family history of Excessive dream disorder', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Did any of your family members has the same complaints, if yes, specify'}, {'measure': 'Depression symptoms', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Beck Depression scale'}, {'measure': 'State anxiety symptoms', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'State anxiety by Spielberger Anxiety Scale'}, {'measure': 'Trait anxiety symptoms', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Trait anxiety by Spielberger Anxiety Scale'}, {'measure': 'Shortened Sleep Questionnaire', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Validated questionnaire to evaluate insomniac complaints, parasomnias, use of medications, hypersomnias, sleep related breathe disorders'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dream', 'epic dream disorder', 'daytime symptoms'], 'conditions': ['Dream Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nIn 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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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;\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT05872594', 'briefTitle': 'Prevalence of a Phenomenon of Epic Dream Disorder', 'organization': {'class': 'OTHER', 'fullName': 'I.M. Sechenov First Moscow State Medical University'}, 'officialTitle': 'Assessing the Prevalence and Associated Risk Factors of a Phenomenon of Epic Dream Disorder: a Cross-sectional Study', 'orgStudyIdInfo': {'id': '0000640001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': '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', 'interventionNames': ['Diagnostic Test: Online questionnaire']}], 'interventions': [{'name': 'Online questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'data will be collected remotely on the online platform Qualtrics', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Mikhail Poluektov, PhD', 'role': 'CONTACT'}, {'name': 'Polina Pchelina, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'II.M. Sechenov First Moscow State Medical University (Sechenov University)', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Polina Pchelina, PhD', 'role': 'CONTACT', 'email': 'polbox@mail.ru, pchelina_p_v@staff.sechenov.ru', 'phone': '+79036701725'}, {'name': 'Mikhail Rumyantsev', 'role': 'CONTACT'}], 'overallOfficials': [{'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', 'affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Polina Pchelina', 'investigatorAffiliation': 'I.M. Sechenov First Moscow State Medical University'}}}}