Relationships Between Sleep Spindle and Cognitive Process in Healthy Adults

NCT04596449 | Completed

• 1 other identifier: CHUBX 2020/24
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Meta-analyses demonstrate that sleep spindles, characterizing NREM sleep, may be a physiological index of high-level cognitive processes. The aim of the study is to determine if sleep spindles can predict interindividual variation in attention and cognitive performance. Relationship between attention and cognitive performance and sleep spindles characteristics (density, frequency and amplitude) recording during 1 night in 80 healthy subject (aged between 18-75y), will be calculated.

Conditions

Sleep

Keywords

Sleep spindles; cognitive processes

Outcome Measures

Primary Outcomes (2)

• Sleep spindle during N2 sleep stage

  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

  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)

Study Arms (1)

healthy volunteers

EXPERIMENTAL

Other: study intervention

Interventions

study intervention OTHER

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.

healthy volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 22, 2020
• Study Start: January 19, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

FR (1)