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

NCT ID: NCT02891343

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2021-05-31

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.

Conditions

Alteration of Cognitive Function; Hypoxia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

Group Type: EXPERIMENTAL

2-hour period of hypoxia

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Régis Bordet

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Centre d'Investigation Clinique, CHRU

Lille, , France

Site Status: NOT_YET_RECRUITING

Centre d'investigation Clinique

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Régis Bordet, MD,PhD

Role: CONTACT

regis.bordet@univ-lille2.fr

Other Identifiers

2014-A00513-44

Identifier Type: OTHER

Identifier Source: secondary_id

2013_44

Identifier Type: -

Identifier Source: org_study_id