- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04596449
Relationships Between Sleep Spindle and Cognitive Process in Healthy Adults (FUSO)
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France
- CHU de Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female subjects, aged 18 to 75,
- BMI between 18 and 27,
- Having no subjective daytime sleepiness (Epworth scale score ≤ 11),
- Subjects affiliated to a social security scheme,
- Subjects capable of understanding the study,
- Subjects available to come to the 2 visits required by the study,
- Having given written informed consent to participate in the study,
- Free, informed and written consent, dated and signed by the patient and the investigator before any examination required by the research,
- For simulated driving sub-study: Having a driving license (subsample).
Exclusion Criteria:
- Severe pathologies involving the short-term vital prognosis,
- Uncontrolled endocrine pathologies (dysthyroidism, diabetes),
- All progressive cardiovascular conditions,
- All progressive neurological conditions treated or not (brain tumor, epilepsy, migraine, stroke, sclerosis, myoclonus, chorea, neuropathy, muscular dystrophies, myotonic dystrophy ...),
- Current Psychiatric disorder: mood disorder (depression, bipolar disorder), anxiety disorder, psychosis
- Substance-related dependence,
- Shift workers or night workers who have been on call or on call in the last 72 hours,
- Psychotropic patients,
- Long-term treatment with benzodiazepines and z-drugs,
- Patients on cardiotropic,
- Deprived of liberty by a judicial or administrative decision,
- Pregnant or lactating woman,
- Subject under curatorship or tutorship.
- For simulated driving sub-study: Having simulator-sickness during the first practice session evaluated by Simulator Sickness Questionnaire (SSQ)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: healthy volunteers
|
The sleep structure of healthy volunteers will be recorded (9 Electroencephalograms (EEG), 2 Electrooculograms (EOG), 2 Electromyograms (EMG) and 2 Electrocardiograms (ECG)) during 1 night. The characteristics of the spindle (density, frequency and amplitude) will be automatically analyzed from purified EEG during Non Rapid Eye Movement sleep (NREM). Volunteers will completed a neuropsychological evaluation that will evaluate Sustained attention (simple reaction time test), Vigilance (TAP Vigilance), Sustained and selective attention (CPT II), Inhibition (Stroop test), Mental flexibility (TAP flexibility) , Executive operation (Tower of London), Short-term memory (Wechsler code test). Driving performance will be analyzed as part of a complex scenario involving attentional and high-level functions on a driving simulator. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep spindle during N2 sleep stage
Time Frame: during experimental visit (between day 1 and day 14 after inclusion)
|
Characteristics of the sleep spindles generated during the N2 sleep stages. The sleep spindles density will be calculated automatically on the EEG Cz and Fz channels. The amplitude and frequency will be calculated automatically on the EEG Cz and Fz channels. The sleep spindles will also be divided, according to their frequency: into fast zones (13-15 Hz) and slow zones (11-13 Hz). |
during experimental visit (between day 1 and day 14 after inclusion)
|
Sleep spindle during N3 sleep stage
Time Frame: during experimental visit (between day 1 and day 14 after inclusion)
|
Characteristics of the sleep spindles generated during the N3 sleep stage. The sleep spindles density will be calculated automatically on the EEG Cz and Fz channels. The amplitude and frequency will be calculated automatically on the EEG Cz and Fz channels. The sleep spindles will also be divided, according to their frequency: into fast zones (13-15 Hz) and slow zones (11-13 Hz). |
during experimental visit (between day 1 and day 14 after inclusion)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- CHUBX 2020/24
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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