SleepFUSONCT04596449
Relationships Between Sleep Spindle and Cognitive Process in Healthy Adults
A study testing study intervention in people with Sleep, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- study intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2021to 16 Dec 2021
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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).
Who cannot join
- 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,
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
It is currently well demonstrated that sleep promotes brain plasticity and therefore is directly involved in cognitive processes such as memory, language, reasoning, learning, intelligence, problem solving…. Sleep deprivation affects most cognitive processes. More specifically, it is the sleep microstructure and in particular the sleep spindles that are specifically linked to memory, learning and cognitive abilities. Sleep spindles are grapho-elements that characterize NREM sleep. They exhibit high inter-individual stability and variability, depend on the genetic heritage and correlate with anatomical properties of the brain. Sleep spindles can therefore be considered as an electrophysiological "finger-print" as one of the most heritable traits of humans. Studies support the notion that sleep spindles are electrophysiological markers of high-level cognitive abilities. It remains to be seen whether the sleep spindles can predict interindividual variations in attention and executive functions.
- Conditions
- Sleep
- Being tested
- study intervention
- Keywords
- Sleep spindles, cognitive processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Not described Receives: Other: study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: during experimental visit (between day 1 and day 14 after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start19 Jan 2021
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596449
- Sponsor's protocol ID
- CHUBX 2020/24
- Acronym
- FUSO
- Status last verified
- Jul 2022
- First submitted
- 8 Oct 2020
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Sleep Spindle and Cognitive Process in Healthy Adults
- ClinicalTrials.gov ID
- NCT04596449
- Acronym / sponsor ID
- FUSO / CHUBX 2020/24
- Conditions
- Sleep
- Keywords
- Sleep spindles, cognitive processes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 22 Oct 2020 (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.
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.
Detailed description
It is currently well demonstrated that sleep promotes brain plasticity and therefore is directly involved in cognitive processes such as memory, language, reasoning, learning, intelligence, problem solving…. Sleep deprivation affects most cognitive processes. More specifically, it is the sleep microstructure and in particular the sleep spindles that are specifically linked to memory, learning and cognitive abilities. Sleep spindles are grapho-elements that characterize NREM sleep. They exhibit high inter-individual stability and variability, depend on the genetic heritage and correlate with anatomical properties of the brain. Sleep spindles can therefore be considered as an electrophysiological "finger-print" as one of the most heritable traits of humans. Studies support the notion that sleep spindles are electrophysiological markers of high-level cognitive abilities. It remains to be seen whether the sleep spindles can predict interindividual variations in attention and executive functions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Other: study intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| study interventionThe 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. | Other | healthy volunteers |
Primary outcome
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).
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).
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 18 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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?
A study testing study intervention in people with Sleep, run by University Hospital, Bordeaux 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 9 inclusion and 14 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 18 Jul 2022. 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?
Sleep spindle during N2 sleep stage (time frame: during experimental visit (between day 1 and day 14 after inclusion)). The study lists 2 primary outcomes in all. 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 18 Jul 2022.