Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers

University Hospital, Lille

Status: Unknown

Conditions: Hypoxia; Alteration of Cognitive Function

Treatments: Other: 2-hour period of hypoxia

Study type: Interventional

Funder types: Other

Identifiers

NCT02891343

2014-A00513-44 (Other Identifier)

2013_44

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Healthy volunteers

Experimental group

Treatment:

Other: 2-hour period of hypoxia