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

Hypoxia Clinical Trial

— Hypoxia  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02891343
• Other study ID #: 2013_44
• Secondary ID: 2014-A00513-44
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 2021

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: Régis Bordet, MD,PhD
• Email: regis.bordet[@]univ-lille2.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Alteration of Cognitive Function
• Hypoxia

Intervention

Other:
• 2-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.

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique, CHRU	Lille
France	Centre d'investigation Clinique	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of adverse events occuring during the period of hypoxia		at the baseline and after the hypoxia session (day0)