Alteration of Cognitive Function, Hypoxia
Conditions
Keywords
Cognitive Function, Hypoxia, Neurophysiological Function, Effect of Alzheimer Disease symptomatic drugs, Healthy Subjects
Brief summary
The early assessment of new symptomatic drugs for Alzheimer disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development. In healthy volunteers, to test the reverse effect of symptomatic drugs, it is necessary to induce transient and reversible cognitive impairment and cerebral activity changes by a challenge test. In this context, a transient hypoxia could be relevant.
Interventions
OTHER2-hour period of hypoxia
During this period, the FiO2 will be set on 21% (normoxia condition). A filter will be put between the mask and the tubes connecting it to the machine generating hypoxia (equipment reference = Altitrainer NP190). On that filter a gas analyser will monitor the FiO2 and a capnography monitor (Capnostream 20, ORIDION) will also be installed.
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Good health on the basis of the medical interview, physical examination and standard biology parameters. * Right-Handed * Non-smoker * No cardiac nor pulmonary pathologies * No use of chronic treatment or psychotropic drugs or substances * BMI inferior to 25 Kg/m2 * French speaker and able to understand the test instructions * Informed consent form signed
Exclusion criteria
1. Subject with history or current brain disease (severe brain trauma, transient ischemic attack, stroke, epilepsy, cerebral tumor…) or retinal pathologies (including familial DMLA) 2. Subject with history of Acute Mountain Sickness, High Altitude Cerebral Edema or High Altitude Pulmonary Edema 3. Subject with other major medical or surgical history including coronaropathy and pulmonary arterial hypertension 4. Subject with current chronic disease 5. Subject with vascular or metabolic risk factor 6. Subject with history of or current mental disease or addiction (MINI) 7. Subject with significant abnormality on biology 8. Subject with significant abnormality on ECG 9. Subject with significant abnormality on MRI 10. Subject with significant abnormality of electrical activities on EEG 11. Subject with family history of young onset dementia 12. Subject with family history of cardiac or pulmonary pathologies 13. Subject with family history of chronic or severe neurological or mental disease (first degree relatives) 14. Subject with claustrophobia or contraindication to MRI 15. Subject under guardianship 16. Subject not covered by Social Security 17. Subject participating in another clinical trial 18. Subject with anxiety (STAI-Trait Score T\> 51) or neuroticism personality (EPI Score N ≥13) 19. Subject bearded or refusing to shave
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery | Between baseline (normoxic period) and Day 0 (hypoxia session ) |
Secondary
| Measure | Time frame |
|---|---|
| The number of adverse events occuring during the period of hypoxia | at the baseline and after the hypoxia session (day0) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORRégis Bordet
University Hospital, Lille
Outcome results
None listed