- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05452733
Toward a Real-time Access to Sleepers' Mental Content (SleepDance)
Sleep is crucial for global cognitive functioning, but its exact functions and mechanisms are still poorly understood. Cognitive studies of sleep typically rely on linking electrophysiological changes measured during sleep with behavioral and neural changes collected in tasks performed during wakefulness. What concomitantly happens in the mind of sleeping subjects is often ignored, certainly because it is virtually inaccessible. Yet, major advances in the understanding of human behaviors have resulted from an integrated approach that combines both neural and cognitive measures of their ongoing mental processes. The goal of this study is to provide real-time measures of the cognitive processes occurring within sleep.
To prompt real-time access to the sleeping mind, investigators will use auditory stimulation in people with unique sleep peculiarities: sleepwalkers whose overt behaviours may enable to objectively visualize ongoing cognitive processes during non-REM (NREM) sleep.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Isabelle Arnulf, MD PhD
- Phone Number: 01 42 16 77 04
- Email: Isabelle.arnulf@aphp.fr
Study Contact Backup
- Name: Delphine Oudiette, PhD
- Phone Number: 01 42 16 77 16
- Email: delphine.oudiette-ext@aphp.fr
Study Locations
-
-
-
Paris, France, 75013
- Recruiting
- Service des Pathologies du Sommeil, Hôpital Pitié-Salpétrière
-
Contact:
- Delphine Oudiette, PhD
- Phone Number: 01 42 16 77 16
- Email: delphine.oudiette-ext@aphp.fr
-
Contact:
- Isabelle Arnulf, MD, PhD
- Phone Number: 01 42 16 77 04
- Email: isabelle.arnulf@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18-35 y.o
- Written consent
- Affiliated to social security
- Sleepwalking (group patients only)
Exclusion Criteria:
- Psychiatric or neurologic disorder
- Sleep disorder except sleepwalking for the patient group
- Surdity
- Pain or physical disability affecting the upper limbs
- Consumption of drugs altering sleep structure
- Subjects under legal protection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleepwalking patient
|
movement registry done by camera when low intensity sound are send to patient during sleep.
|
Active Comparator: Non sleepwalking patient
|
movement registry done by camera when low intensity sound are send to patient during sleep.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral reaction
Time Frame: 2 days
|
number of behavioral reactivations of the motor sequence following the auditory cues during sleep
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of targeted memory reactivation (TMR) success in sleepwalkers by movements test
Time Frame: 2 days
|
test whether performance is better for movements that have been cued during sleep (vs.
uncued ones) in sleepwalkers
|
2 days
|
Quantification of movements exhibited during sleep
Time Frame: 2 days
|
The quantification of movement will be evaluated by combinaison of the reaction time, speed and precision of movements exhibited by sleepwalkers during sleep vs. wakefulness
|
2 days
|
Determination of the link between dream and sensory cues
Time Frame: 2 days
|
Comparison between the number of dreams related to the motor sequence on the 2nd night (after TMR) vs. during the 1st one.
|
2 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Isabelle Arnulf, MD PhD, APHP
- Study Director: Delphine Oudiette, PhD, Institut National de la Santé Et de la Recherche Médicale, France
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP220764
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.
Clinical Trials on Sleepwalking
-
Assistance Publique - Hôpitaux de ParisCompleted
-
University Hospital, MontpellierWithdrawnNREM Parasomnia | Sleepwalking | Sleep TerrorFrance
Clinical Trials on differences of behavior between sleepwalking and non sleepwalking patient
-
Jules Bordet InstituteUniversité Libre de Bruxelles; Fondation Kisane; Les Amis de l'InstitutUnknownAdults | Hematological Malignancy | Oral Antineoplastic AgentsBelgium
-
Hamilton Health Sciences CorporationOntario Ministry of Health and Long Term Care; Canadian Health Services Research... and other collaboratorsCompleted
-
University of MichiganAssociation of University Radiologists; GE Radiology Research Academic FellowshipCompletedAdenomyosis | Uterine Fibroids | Uterine BleedingUnited States
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)RecruitingObesity | Overweight | Overweight and ObesityUnited States
-
Federal University of São PauloCompletedStroke | Subarachnoid Hemorrhage | Intracranial Hypertension | Stroke, Ischemic | Stroke HemorrhagicBrazil
-
Robert Wood Johnson FoundationCompletedDiabetes MellitusUnited States
-
NorthShore University HealthSystemNorthwestern University; physIQ, Inc.; Carnegie Mellon UniversityCompleted
-
Memorial Sloan Kettering Cancer CenterRecruitingBreast CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterRecruitingBreast CancerUnited States
-
Samsun UniversityCompletedAnalgesia | Acute Pain | Pain ManagementTurkey