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Dream DisorderNCT05872594

Prevalence of a Phenomenon of Epic Dream Disorder

An observational study of Dream Disorder, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dream Disorder
What is being tested?
Online questionnaire
How many people
1,000 participants
Where
1 siteRussia
Study dates
30 Sep 2022to 30 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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;

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mikhail Rumyantsev contact

Russia1 site, 1 recruiting
  • II.M. Sechenov First Moscow State Medical University (Sechenov University)

    Moscow

    Mikhail Poluektov, PhD

    Polina Pchelina, PhD

    Recruiting

Other trials in Russia

About this study

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

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.

Read the 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.

Conditions
Dream Disorder
Being tested
Online questionnaire
Keywords
dream, epic dream disorder, daytime symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online questionnaireDiagnostic test

    data will be collected remotely on the online platform Qualtrics

Study groups in NCT05872594
Study groupRoleWhat they receive
study groupall 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
Receives: Diagnostic Test: Online questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through study completion, an average of 1 year

Secondary outcomes (62)
  1. Demographic outcomes: Sex

    options (male, female)

    Measured: Through study completion, an average of 1 year

  2. Demographic outcomes: Age

    Age in years

    Measured: Through study completion, an average of 1 year

  3. Demographic outcomes: Weight

    Weight in kg

    Measured: Through study completion, an average of 1 year

  4. Demographic outcomes: Height

    Height in cm

    Measured: Through study completion, an average of 1 year

  5. Demographic outcomes: Level of education

    choose category for the level of education

    Measured: Through study completion, an average of 1 year

  6. Demographic outcomes: name the University

    For students only

    Measured: Through study completion, an average of 1 year

  7. Demographic outcomes: name your department

    For students only

    Measured: Through study completion, an average of 1 year

  8. Demographic outcomes: year of study

    For students only

    Measured: Through study completion, an average of 1 year

  9. Demographic outcomes: Employment status

    choose category for the employment status and specify your scope of activities if any

    Measured: Through study completion, an average of 1 year

  10. use of nicotine

    Fact and frequency of use of nicotine

    Measured: Through study completion, an average of 1 year

  11. use of alcohol

    Fact and frequency of use of alcohol

    Measured: Through study completion, an average of 1 year

  12. Medical history

    Presence of any chronic illnesses (specify the name)

    Measured: Through study completion, an average of 1 year

  13. duration of complaints

    Question: how long do you experience multiple dreams

    Measured: Through study completion, an average of 1 year

  14. Average duration of sleep

    hours

    Measured: Through study completion, an average of 1 year

  15. dreams during daytime nap

    Presence of dreams during daytime nap (yes or no)

    Measured: Through study completion, an average of 1 year

  16. Amount of dreams during the night

    specify number (0, 1, 2, 3 and more)

    Measured: Through study completion, an average of 1 year

  17. discomfort after the night of active dreaming

    Presence of discomfort after the night of active dreaming in the morning or during the day

    Measured: Through study completion, an average of 1 year

  18. triggers of active dreaming

    Were you able to identify a factor or event that triggered the appearance of multiple dreams? If yes, specify.

    Measured: Through study completion, an average of 1 year

  19. Intensity of thought activity in dream

    range 1-5

    Measured: Through study completion, an average of 1 year

  20. Intensity of speech activity in dream

    range 1-5

    Measured: Through study completion, an average of 1 year

  21. Intensity of running in dream

    range 1-5

    Measured: Through study completion, an average of 1 year

  22. Intensity of walking in dream

    range 1-5

    Measured: Through study completion, an average of 1 year

  23. Intensity of monotonous physical movements in dream

    range 1-5

    Measured: Through study completion, an average of 1 year

  24. Intensity of flight in dream

    range 1-5

    Measured: Through study completion, an average of 1 year

  25. Intensity of swimming in dream

    range 1-5

    Measured: Through study completion, an average of 1 year

  26. Intensity of jumping in dream

    range 1-5

    Measured: Through study completion, an average of 1 year

  27. Intensity of trip by transport in dream

    range 1-5

    Measured: Through study completion, an average of 1 year

  28. 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

    Measured: Through study completion, an average of 1 year

  29. characteristics of dream content

    Intensity of positive emotions (range 1-5)

    Measured: Through study completion, an average of 1 year

  30. characteristics of dream content

    Intensity of negative emotions (range 1-5)

    Measured: Through study completion, an average of 1 year

  31. Impression that your brain stays awake while you sleep

    range 1-5

    Measured: Through study completion, an average of 1 year

  32. Any peculiarities of your dream

    specify

    Measured: Through study completion, an average of 1 year

  33. 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

    Measured: Through study completion, an average of 1 year

  34. 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

    Measured: Through study completion, an average of 1 year

  35. 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

    Measured: Through study completion, an average of 1 year

  36. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Heart palpitations

    Measured: Through study completion, an average of 1 year

  37. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Shortness of breath

    Measured: Through study completion, an average of 1 year

  38. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Hyperhidrosis

    Measured: Through study completion, an average of 1 year

  39. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom feeling Cold

    Measured: Through study completion, an average of 1 year

  40. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Fatigue

    Measured: Through study completion, an average of 1 year

  41. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Bad mood

    Measured: Through study completion, an average of 1 year

  42. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Muscle pain

    Measured: Through study completion, an average of 1 year

  43. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Headache

    Measured: Through study completion, an average of 1 year

  44. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Pain in chest

    Measured: Through study completion, an average of 1 year

  45. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Balance disturbance

    Measured: Through study completion, an average of 1 year

  46. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Loss of tactile sensitivity

    Measured: Through study completion, an average of 1 year

  47. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Tingling/frowning sensation

    Measured: Through study completion, an average of 1 year

  48. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Anxiety

    Measured: Through study completion, an average of 1 year

  49. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Weakness

    Measured: Through study completion, an average of 1 year

  50. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the symptom Nausea

    Measured: Through study completion, an average of 1 year

  51. Subjective symptoms in the morning after a night of active dreaming

    Presence and length of the other symptoms, if any

    Measured: Through study completion, an average of 1 year

  52. Use of medications

    Question about the use of medication, no or yes (specify the name)

    Measured: Through study completion, an average of 1 year

  53. Dose of medications

    Question about the dose of medication, if any

    Measured: Through study completion, an average of 1 year

  54. Frequency of medications

    Question about the frequency of medications use, if any

    Measured: Through study completion, an average of 1 year

  55. awakenings during the night

    Number of awakenings during the night

    Measured: Through study completion, an average of 1 year

  56. Frequency of nights with multiple dreams

    Number of nights per week

    Measured: Through study completion, an average of 1 year

  57. Seasonal fluctuation of the multiple dreams

    During which season do the multiple dreams occur more often

    Measured: Through study completion, an average of 1 year

  58. Family history of Excessive dream disorder

    Did any of your family members has the same complaints, if yes, specify

    Measured: Through study completion, an average of 1 year

  59. Depression symptoms

    Beck Depression scale

    Measured: Through study completion, an average of 1 year

  60. State anxiety symptoms

    State anxiety by Spielberger Anxiety Scale

    Measured: Through study completion, an average of 1 year

  61. Trait anxiety symptoms

    Trait anxiety by Spielberger Anxiety Scale

    Measured: Through study completion, an average of 1 year

  62. Shortened Sleep Questionnaire

    Validated questionnaire to evaluate insomniac complaints, parasomnias, use of medications, hypersomnias, sleep related breathe disorders

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start30 Sep 2022
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05872594
Sponsor's protocol ID
0000640001
Status last verified
May 2023
First submitted
27 Sep 2022
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Dream Disorder, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Polina Pchelina, PhD (+79036701725, polbox@mail.ru, pchelina_p_v@staff.sechenov.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of the phenomenon of epic dream disorder (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

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