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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers WP1 P002 PHARMACOG

Conditions
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Alteration of Cognitive Function, Hypoxia

Intervention / Treatment
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* Other: 2-hour period of hypoxia


Participation Criteria
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Eligibility Criteria
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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: Subject with history or current brain disease (severe brain trauma, transient ischemic attack, stroke, epilepsy, cerebral tumor…) or retinal pathologies (including familial DMLA) Subject with history of Acute Mountain Sickness, High Altitude Cerebral Edema or High Altitude Pulmonary Edema Subject with other major medical or surgical history including coronaropathy and pulmonary arterial hypertension Subject with current chronic disease Subject with vascular or metabolic risk factor Subject with history of or current mental disease or addiction (MINI) Subject with significant abnormality on biology Subject with significant abnormality on ECG Subject with significant abnormality on MRI Subject with significant abnormality of electrical activities on EEG Subject with family history of young onset dementia Subject with family history of cardiac or pulmonary pathologies Subject with family history of chronic or severe neurological or mental disease (first degree relatives) Subject with claustrophobia or contraindication to MRI Subject under guardianship Subject not covered by Social Security Subject participating in another clinical trial Subject with anxiety (STAI-Trait Score T> 51) or neuroticism personality (EPI Score N ≥13) Subject bearded or refusing to shave

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br> | Other: 2-hour period of hypoxia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events occuring during the period of hypoxia |  | at the baseline and after the hypoxia session (day0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Function, Hypoxia, Neurophysiological Function, Effect of Alzheimer Disease symptomatic drugs, Healthy Subjects