EpilepsyEPIDREAM 1NCT05561166
EPIDREAM 1 : Study of Dreaming in Epilepsy
An observational study of Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Dreaming is a sleep-associated cognitive process whose neural substrates and functions remain poorly understood. In healthy subjects, the frequency of dream recall is influenced by several factors such as age, gender, interest in dreams and sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- EPIDREAM Questionnaire
- How many people
- 347 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2023to 21 Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 consecutives out-patients with epilepsy seen at the consultation of the Epilepsy and Functional Neurology Department, Lyon Neurological Hospital.
Who may be able to join
- Patient seen at the epilepsy consultation
- Age 18-65 years
- Certain diagnosis of epilepsy whatever the syndromic diagnosis and the frequency of seizures
Who cannot join
- major cognitive disorders
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Determinants of Dream Recall and Content in Patients With Epilepsy
Dreaming is a sleep-associated cognitive process whose neural substrates and functions remain poorly understood. In healthy subjects, the frequency of dream recall is influenced by several factors such as age, gender, interest in dreams and sleep quality. The content of dreams mainly depends on waking life experiences, especially when they are recent and have a strong emotional content. The function of dreams remains debated but it is widely accepted that dreams play a role in emotional regulation.
Modifications in dreams are observed in several neurological diseases and sleep disorders, due to the modifications of sleep related to these diseases, as well as to associated disturbances in cognitive functioning and to the impact on such diseases on waking life. Epilepsy is a neurological condition characterized by a predisposition to seizures resulting from excessive and synchronized abnormal brain activity; it is associated with numerous co-morbidities including sleep and cognitive disorders, which are present in nearly one in two patients. However, the influence of epilepsy on sleep-related cognitive processes is poorly understood. It is suspected that nocturnal epileptic activity disturbs sleep-related memory consolidation processes, but the consequences of epilepsy on dreams have been little investigated.
Read more
The study of the determinants (epilepsy syndrome, location of the epileptic focus, presence of sleep-related seizures, certain anti-epileptic treatments, alteration of the quality of sleep) of dream characteristics in this context could lead to a better understanding of the dreams physiology, the interactions between epilepsy and sleep, as well as the cognitive and emotional functioning related to sleep in epilepsy. It could also determine whether dream characteristics can provide information on the epilepsy syndrome and on the presence of nocturnal seizures, and thus constitute a diagnostic tool.
In this cross-sectional observational study, we aim to identify determinants of dream recall in relation to epilepsy by administering a simple and brief questionnaire on sleep and dreams, to all consecutive patients seen in epileptology consultation during 12 months. Our objectives are
- To determine whether the presence of sleep-related seizures influences the frequency of dream recall in patients with epilepsy
- To describe the characteristics of dreams in epilepsy, the influence of epilepsy on dreams and to characterize the determinants of dream recall frequency in patients with epilepsy We hypothesize that the presence of seizures during sleep will be associated with poorer sleep quality, increased frequency of dream recall, and that we will observe the inclusion of epilepsy symptoms in dream content, particularly in subjects who are aware of their nocturnal seizures and are awakened by them.
- Conditions
- Epilepsy
- Being tested
- EPIDREAM Questionnaire
- Keywords
- Epilepsy, Dreams, Seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIDREAM QuestionnaireOther
EPIDREAM Questionnaire (questionnaire about dreams and epileptic seizures)
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between dream recall frequency and nocturnal seizures frequency
dream recall frequency : question 1 of the EPIDREAM questionnaire nocturnal seizures frequency: question 12 of the EPIDREAM questionnaire
Measured: Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start7 Feb 2023
- Primary completion21 Jan 2024
- Study completion21 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561166
- Sponsor's protocol ID
- 69HCL22_0745
- Acronym
- EPIDREAM 1
- Status last verified
- Jan 2023
- First submitted
- 27 Sep 2022
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Determinants of Dream Recall and Content in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT05561166
- Acronym / sponsor ID
- EPIDREAM 1 / 69HCL22_0745
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Dreams, Seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- 21 Jan 2024 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dreaming is a sleep-associated cognitive process whose neural substrates and functions remain poorly understood. In healthy subjects, the frequency of dream recall is influenced by several factors such as age, gender, interest in dreams and sleep quality. The content of dreams mainly depends on waking life experiences, especially when they are recent and have a strong emotional content. The function of dreams remains debated but it is widely accepted that dreams play a role in emotional regulation.
Modifications in dreams are observed in several neurological diseases and sleep disorders, due to the modifications of sleep related to these diseases, as well as to associated disturbances in cognitive functioning and to the impact on such diseases on waking life. Epilepsy is a neurological condition characterized by a predisposition to seizures resulting from excessive and synchronized abnormal brain activity; it is associated with numerous co-morbidities including sleep and cognitive disorders, which are present in nearly one in two patients. However, the influence of epilepsy on sleep-related cognitive processes is poorly understood. It is suspected that nocturnal epileptic activity disturbs sleep-related memory consolidation processes, but the consequences of epilepsy on dreams have been little investigated.
The study of the determinants (epilepsy syndrome, location of the epileptic focus, presence of sleep-related seizures, certain anti-epileptic treatments, alteration of the quality of sleep) of dream characteristics in this context could lead to a better understanding of the dreams physiology, the interactions between epilepsy and sleep, as well as the cognitive and emotional functioning related to sleep in epilepsy. It could also determine whether dream characteristics can provide information on the epilepsy syndrome and on the presence of nocturnal seizures, and thus constitute a diagnostic tool.
In this cross-sectional observational study, we aim to identify determinants of dream recall in relation to epilepsy by administering a simple and brief questionnaire on sleep and dreams, to all consecutive patients seen in epileptology consultation during 12 months. Our objectives are
- To determine whether the presence of sleep-related seizures influences the frequency of dream recall in patients with epilepsy
- To describe the characteristics of dreams in epilepsy, the influence of epilepsy on dreams and to characterize the determinants of dream recall frequency in patients with epilepsy We hypothesize that the presence of seizures during sleep will be associated with poorer sleep quality, increased frequency of dream recall, and that we will observe the inclusion of epilepsy symptoms in dream content, particularly in subjects who are aware of their nocturnal seizures and are awakened by them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 consecutives out-patients with epilepsy seen at the consultation of the Epilepsy and Functional Neurology Department, Lyon Neurological Hospital.
Key inclusion criteria (3 listed)
- Patient seen at the epilepsy consultation
- Age 18-65 years
- Certain diagnosis of epilepsy whatever the syndromic diagnosis and the frequency of seizures
Key exclusion criteria (2 listed)
- major cognitive disorders
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPIDREAM QuestionnaireEPIDREAM Questionnaire (questionnaire about dreams and epileptic seizures) | Other | – |
Primary outcome
Correlation coefficient between dream recall frequency and nocturnal seizures frequency
Time frame: Visit 1
dream recall frequency : question 1 of the EPIDREAM questionnaire nocturnal seizures frequency: question 12 of the EPIDREAM questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jan 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between dream recall frequency and nocturnal seizures frequency (time frame: Visit 1). 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 26 Jan 2024.