Influence of Light on Sleep, Awakening, Electroencephalogram (EEG) and Cognitive Performances, and Medical Technology Assessment for Registration and Long-term EEG Analysis
| Registry | NCT02858765, acronym CHRONOSOMNO |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, basic science |
| Enrollment | 92 (Actual) |
| Sponsor | University Hospital, Strasbourg, France (Other) |
| Conditions | Human Sleep and Chronobiology |
| Interventions | Application of white polychromatic light for 2h30 at different times of day (Other) |
| Dates | start 2016-06-01, primary completion 2019-06-01, completion 2019-06-01, first posted 2016-08-08, last updated 2025-12-19 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Human Sleep and Chronobiology All trials of Application of white polychromatic light for 2h30 at different times of day
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| white polychromatic light A | Experimental | Other: Application of white polychromatic light for 2h30 at different times of day | |
| white polychromatic light B | Experimental | Other: Application of white polychromatic light for 2h30 at different times of day | |
| white polychromatic light C | Experimental | Other: Application of white polychromatic light for 2h30 at different times of day | |
| white polychromatic light D | Experimental | Other: Application of white polychromatic light for 2h30 at different times of day |
Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers
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| Facility | City | Country | Status |
|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Strasbourg | France |