Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances

Human Sleep and Chronobiology Clinical Trial

— CHRONOSOMNO  

Official title:

Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances, and Medical Technology Assessment for Registration and Long-term EEG Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858765
• Other study ID #: 6187
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to study the influence of light on sleep, wakefulness, EEG activity and cognitive performances. The study aim also to evaluate techniques for registration and analysis of the EEG over periods of time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male or female

• Aged 18 to 40 years

• With a hint of Bodymass index (BMI) between 17 and 30 kg.m - 2

• Healthy subject determined by a clinical examination, a psychological interview, a blood test, a urine analysis and an ophthalmologic examination

• Topic Subject with a score <6 questionnaire PSQI ("Sleep Questionnaire Pittsburgh")

• Subject agreeing to maintain a regular sleep/wake rhythm during the study

• Subject agreeing to refrain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs during the study

• Signed informed consent

• Subject affiliated to a social protection scheme

Exclusion Criteria:

• somatic diseases: cardiovascular, respiratory, gastrointestinal, hematopoietic, Visual

• immune system diseases

• kidneys and urinary tract diseases

• endocrine and metabolic diseases

• neurological diseases

• infectious diseases

• thrombocytopenia or other malfunction of blood platelets

• Subject with risk of thrombosis, including subject with a history of phlebitis, smoker under oral contraceptive...

• Subject with an addiction to caffeine, nicotine, alcohol, psychotropic drugs, cannabis, or any other drug

• Subject treatment contraindicated or inadvisable in combination with heparin

• Allergy to neoprene or lycra

• Dysfunction of the temporomandibular joint (TMJD)

• Blood donation in the previous 3 months before the inclusion

• Participation in other clinical trials in the previous 3 months before the inclusion

• Work by shifts in the year preceding the inclusion

• Trans-meridian travel (> 2 time zones) in the month previous the inclusion

• Contraindications to the use of the medical device

• Impossibility to give enlightened information (subject in an emergency situation, understanding difficulties,...)

• Subject under safeguard of justice

• Subject under tutorship or curatorship

• Pregnancy (women of childbearing age)

• Breastfeeding

Related Conditions & MeSH terms

• Human Sleep and Chronobiology

Intervention

Other:
• Application of white polychromatic light for 2h30 at different times of day

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	STRASBOURG Cedex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of EEG activity	sleep fragmentation	up to 56 hours
Primary	Cognitive performances assessed using Psychomotor vigilance task (PVT)	Psychomotor vigilance task (PVT)	up to 56 hours
Primary	Cognitive performances assessed using Sustained Attention to Response Task (SART)	Sustained Attention to Response Task (SART)	up to 56 hours
Primary	Cognitive performances assessed using Digit Symbol Substitution Test (DSST)	Digit Symbol Substitution Test (DSST)	up to 56 hours
Primary	Cognitive performances assessed using N-back tasks	N-back tasks	up to 56 hours
Primary	Cognitive performances assessed using Paced Visual Serial Addition Task (PVSAT)	Paced Visual Serial Addition Task (PVSAT)	up to 56 hours
Primary	Cognitive performances assessed using Visual analogue scales (VAS) for motivation	Visual analogue scales (VAS) for motivation	up to 56 hours
Primary	Cognitive performances assessed using Positive and Negative Affect Scale (PANAS)	Positive and Negative Affect Scale (PANAS)	up to 56 hours
Primary	Cognitive performances assessed using Karolinska Sleepiness Scale (KSS)	Karolinska Sleepiness Scale (KSS)	up to 56 hours
Primary	Cognitive performances assessed using Visual Comfort Scale (VCS)	Visual Comfort Scale (VCS)	up to 56 hours
Primary	Cognitive performances assessed using Racing and Crowded Thoughts Questionnaire (RCTQ)	Racing and Crowded Thoughts Questionnaire (RCTQ)	up to 56 hours
Primary	Cognitive performances assessed using Mental Effort Rating Scale (RSME)	Mental Effort Rating Scale (RSME)	up to 56 hours
Primary	Cognitive performances assessed using Karolinska Drowsiness Test (KDT)	Karolinska Drowsiness Test (KDT)	up to 56 hours