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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypoxia; Alteration of Cognitive Function
• Intervention / Treatment: Other: 2-hour period of hypoxia

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Régis Bordet, MD,PhD; Email: regis.bordet@univ-lille2.fr

Study Locations

• France
  • Lille, France
    • Not yet recruiting
    • Centre d'Investigation Clinique, CHRU
    • Principal Investigator: Elsa Jozefowicz, MD
  • Marseille, France
    • Recruiting
    • Centre d'Investigation Clinique
    • Principal Investigator: Christine Audebert, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers	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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Régis Bordet, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Hypoxia; Healthy Subjects; Cognitive Function; Neurophysiological Function; Effect of Alzheimer Disease symptomatic drugs
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 2013_44; 2014-A00513-44 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO