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

Primary Purpose

Alteration of Cognitive Function, Hypoxia

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

2-hour period of hypoxia

About this trial

This is an interventional other trial for Alteration of Cognitive Function focused on measuring Cognitive Function, Hypoxia, Neurophysiological Function, Effect of Alzheimer Disease symptomatic drugs, Healthy Subjects

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts 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:

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

Sites / Locations

Centre d'Investigation Clinique, CHRU
Centre d'investigation CliniqueRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery

Secondary Outcome Measures

The number of adverse events occuring during the period of hypoxia

Full Information

NCT ID

NCT02891343

First Posted

September 1, 2016

Last Updated

August 25, 2020

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT02891343

Brief Title

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

Acronym

Hypoxia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (Actual)

Primary Completion Date

May 2021 (Anticipated)

Study Completion Date

May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alteration of Cognitive Function, Hypoxia

Keywords

Cognitive Function, Hypoxia, Neurophysiological Function, Effect of Alzheimer Disease symptomatic drugs, Healthy Subjects

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy volunteers

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

2-hour period of hypoxia

Intervention Description

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.

Primary Outcome Measure Information:

Title

the mean of response latency to the Rapid Visual Information Processing (RVIP) test of the CANTAB battery

Time Frame

Between baseline (normoxic period) and Day 0 (hypoxia session )

Secondary Outcome Measure Information:

Title

The number of adverse events occuring during the period of hypoxia

Time Frame

at the baseline and after the hypoxia session (day0)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Régis Bordet, MD,PhD

regis.bordet@univ-lille2.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Régis Bordet

Organizational Affiliation

University Hospital, Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre d'Investigation Clinique, CHRU

City

Lille

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elsa Jozefowicz, MD

Facility Name

Centre d'investigation Clinique

City

Marseille

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine Audebert, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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